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Food safety guides for groups most vulnerable to foodborne illness now available
Food safety guides for groups most vulnerable to foodborne illness now available
Source: U.S. Food and Drug Administration
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and the Department of Health and Human Services’ Food and Drug Administration (FDA) have partnered to create six booklets with food safety advice for populations that are most susceptible to foodborne illness. The booklets in this “at-risk series” are tailored to help older adults, transplant recipients, pregnant women, and people with cancer, diabetes or HIV/AIDS reduce their risk for foodborne illness.
“These booklets are a much needed resource for consumers who are at increased risk of getting sick from food,” said USDA Under Secretary for Food Safety Dr. Elisabeth Hagen. “The clear, understandable information in these booklets will help at-risk individuals feel confident about the safety of foods they prepare and eat. The booklets are also helpful to physicians and other health care providers for educating their at-risk patients about foodborne illnesses.”
Each of the booklets contains 24 pages of practical guidance on how to prevent foodborne illness. The information is presented in easy-to-read charts, illustrated how-tos, and straightforward descriptions of why each group is at higher risk for foodborne illness and symptoms that may mean trouble. The booklets contain three tear-out cards with quick-reference tips for grocery shopping, cooking to the right temperature, and eating at restaurants for times when taking along the entire booklet would be impractical.
“Everyone from farmers to food manufacturers to food preparers in the home has a role in food safety,” said FDA Deputy Commissioner for Foods Michael Taylor. “It is important that consumers, particularly those who are at higher risk of foodborne illness, have information they can use to do their part in preventing illness by properly selecting and preparing foods.”
While booklets on five of these topics were previously produced in 2006, the two agencies this year created a sixth booklet for pregnant women, who are at particular risk for the illness listeriosis. The six new booklets list food safety resources, such as www.foodsafety.gov, that have been made available since the earlier copies were printed. They also include revised safe cooking temperatures for meat and poultry: 145 °F for whole cuts of meat, followed by a three-minute rest time; 160 °F for ground meats; and 165 °F for all poultry and leftovers.
CRS — How FDA Approves Drugs and Regulates Their Safety and Effectiveness
How FDA Approves Drugs and Regulates Their Safety and Effectiveness (PDF)
Source: Congressional Research Service (via Federation of American Scientists)
The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers’ applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA’s responsibilities regarding drug approval and regulation.
The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug’s proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug’s identify, strength, quality, and identity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements at each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track applications, and priority review.
Once a drug is on the U.S. market (following FDA approval of the NDA), FDA continues to address drug production, distribution, and use. Its activities, based on ensuring drug safety and effectiveness, address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and directto-consumer advertising, all topics in which Congress has traditionally been interested.
FDA seeks to ensure product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs. FDA’s approval of an NDA includes the drug’s labeling; the agency may require changes once a drug is on the market based on new information. It also prohibits manufacturer promotion of uses that are not specified in the labeling. The FFDCA requires that manufacturers report to FDA adverse events related to its drugs; clinicians and other members of the public may report adverse events to FDA. The agency’s surveillance of drug-related problems, which had primarily focused on analyses of various adverse-event databases, is now expanding to more active uses of evolving computer technology and linking to other public and private information sources.
The FFDCA allows FDA to require a manufacturer to conduct postapproval studies of drugs. The law specifies when FDA must attach the requirement to the NDA approval and when FDA may issue the requirement after a drug is on the market. To manage exception risks of drugs, FDA may require patient or clinician guides and restrictions on distribution. The agency publicly disseminates information about drug safety and effectiveness; and regulates the industry promotion of products to clinicians and the public.
See also: FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective (PDF)
See also: FDA Regulation of Medical Devices (PDF)
See also: The FDA Medical Device User Fee Program (PDF)
Medicines to Help You: Depression
Lists the brands and generic names of various anti-depressants. Learn the side effects, who should not take them, and warning signs regarding harmful drug and food interactions.
Bad Bug Book 2nd Edition — Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
Bad Bug Book 2nd Edition — Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
Source: U.S. Food and Drug Administration
The second edition of the Bad Bug Book, published by the Center for Food Safety and Applied Nutrition, of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services, provides current information about the major known agents that cause foodborne illness. The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference. Each chapter in this book is about a pathogen – a bacterium, virus, or parasite – or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses. A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.
+ Full Document (PDF)
Hat tip: PW
Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
BackgroundPublication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.Methods and FindingsFDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.ConclusionsThe magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.
FDA announces safety changes in labeling for some cholesterol-lowering drugs
FDA announces safety changes in labeling for some cholesterol-lowering drugs
Source: U.S. Food and Drug Administration
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” said Mary Parks, M.D., director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research.
The changes to the statin labels are:
- The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
- Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.
- Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.
- Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.
FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”
Certain medical products may elicit different responses in women than in men. This may be due in part to basic differences in men and women, including genetics, hormones, body size, diet, and sociocultural issues. In addition, certain variables associated with women, such as size or certain illnesses, may be responsible for certain differences between men and women in the safety and effectiveness of medical devices.
+ Draft Guidance: Evaluation of Sex Differences in Medical Device Clinical Studies
FDA approves first cord blood product
FDA approves first cord blood product
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today approved HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy.
HEMACORD is indicated for use in hematopoietic stem cell transplantation procedures in patients with disorders affecting the hematopoietic (blood forming) system. For example, cord blood transplants have been used to treat patients with certain blood cancers and some inherited metabolic and immune system disorders.
“The use of cord blood hematopoietic progenitor cell therapy offers potentially life-saving treatment options for patients with these types of disorders,” said Karen Midthun, M.D., director, FDA’s Center for Biologics Evaluation and Research.
HEMACORD contains hematopoietic progenitor cells (HPCs) from human cord blood. Cord blood is one of three sources of HPCs used in transplants; the other two are bone marrow and peripheral blood. Once these HPCs are infused into patients, the cells migrate to the bone marrow where they divide and mature. When the mature cells move into the bloodstream they can partially or fully restore the number and function of many blood cells, including immune function.
+ Guidance document (PDF)
+ Approved Products
FDA: 35 innovative new drugs approved in fiscal year 2011
FDA: 35 innovative new drugs approved in fiscal year 2011
Source: U.S. Food and Drug Administration
Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained.
The report shows faster approval times in the United States when compared to the FDA’s counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.
Why We Can’t Wait: Taking Action to Reduce Prescription Drug Shortages
Why We Can’t Wait: Taking Action to Reduce Prescription Drug Shortages
Source: White House
Sometimes the most important component of a patient’s treatment is the type of medication they receive and the consistency at which they receive it. For some Americans, a change in their treatment regimen or a substitution of a medication can seriously threaten their ability to get better.
Between 2005 and 2010, the number of prescription drug shortages nearly tripled. While the FDA successfully prevented 137 drug shortages between January 1, 2010 and September 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people. Today, too many people are waiting for their prescription to become available. Some are forced to switch from the medication they prefer, while others go without their medicine altogether. In some cases, drug shortages can even force people to stop a course of treatment before it finishes.
We cannot control the factors that cause these drug shortages. But we are committed to doing our part to counteract them. Which is why President Obama signed an Executive Order today that will lead to earlier FDA notification of any impending shortages for certain prescription drugs. Early notification can help prevent a shortage from becoming a crisis by allowing hospitals, doctors and manufacturers to take action to ensure medications remain available.
In addition, the President’s Executive Order will call on FDA to work with the Justice Department to examine whether “gray market” profiteers are responding to potential drug shortages either by hoarding medications or charging exorbitant prices. In recent months, we’ve heard reports of enormous markups such as a blood pressure medicine usually priced at $26 being sold for $1,200. And under this Executive Order, the Justice Department will watch the market closely to make sure companies are not exploiting drug shortages to raise their profits at the expense of patients.
+ Executive Order — Reducing Prescription Drug Shortages
+ Economic Analysis of the Causes of Drug Shortages (Assistant Secretary for Planning and Evaluation)
+ A Review of FDA’s Approach to Medical Product Shortages (U.S. Food and Drug Administration)
New From the GAO
New GAO Report (PDFs)
Source: Government Accountability office
1. Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters. GAO-11-607, September 8.
http://www.gao.gov/products/GAO-11-607
Highlights - http://www.gao.gov/highlights/d11607high.pdf
Animal Drug Shortage Information
Animal Drug Shortage Information
Source: U.S. Food and Drug Administration
This page contains up-to-date information on potential, current, and resolved shortages of animal drugs. It also includes links to information on human drug shortages that may impact veterinary practice.
A drug shortage may involve either an actual or a potential shortage of a drug product. When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the U.S. and, when necessary, other countries, to find ways to resolve shortages of medically necessary veterinary products. FDA does not have the authority to require a company to make any product, even if it is medically necessary.
FDA outlines plans for an outside network of scientific experts
FDA outlines plans for an outside network of scientific experts
Source: U.S. Food and Drug Administration
FDA’s Center for Devices and Radiological Health (CDRH) is soliciting comment on a plan to create a network of outside scientific experts who would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics. To further enrich this comment period, CDRH will also conduct a 12-week pilot of the network through Dec. 30, 2011.
CDRH has a world-class scientific staff that includes scientists, engineers, and clinicians. Nevertheless, there are times when staff must turn to external sources to further enhance their scientific understanding, given the rapid advancements in certain scientific fields, the development of pioneering technologies and increasingly complex medical devices.
The CDRH Network of Experts would allow CDRH staff to tap into a vetted network of scientists and engineers for detailed scientific information on topics related to medical devices.
CDRH already uses outside experts for its advisory panels. But panel membership is limited to a pool of Special Government Employees who must be recruited and enrolled. The Center cannot be assured that an expert in an emerging technology will be available when that expertise is needed. Other traditional sources of external expertise, such as public workshops, conferences and literature may lag behind current research or may not be available when a scientific question arises at CDRH.
“Medical devices continue to become more diverse and complex. The CDRH Network of Experts will help us broaden our existing expertise and expose our staff to a variety of scientific viewpoints, especially on emerging technology,” said William Maisel, M.D., CDRH deputy center director and chief scientist.
Members of the Network of Experts will not provide policy advice or opinions. Instead, network members will share their particular expertise on specific topics to help center staff form their own conclusions.
+ Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT)
+ Network of Experts – Expert Enrollment Standard Operating Procedure (DRAFT)
FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.
Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs to propel the medicine out of the inhaler so that consumers can breathe it into their lungs.
However, Primatene Mist will no longer be available by year’s end because no CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. This is an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs, after certain dates.
“If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
+ Phase-Out of Epinephrine CFC Metered-Dose Inhalers
+ Epinephrine CFC Metered-dose Inhalers – Questions and Answers
+ Consumer Update: Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011
FDA examines ways to improve consumer understanding of prescription drug ads
FDA examines ways to improve consumer understanding of prescription drug ads
Source: U.S. Food and Drug Administration
Findings from three studies conducted by the U.S. Food and Drug Administration confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
The studies, designed by experts in FDA’s Division of Drug, Marketing, Advertising and Communications (DDMAC) in the Center for Drug Evaluation and Research, examined ways to improve understanding of how consumers use the “brief summary” section of printed prescription drug ads.
The online edition of the journal “Medical Decision Making” published findings from the third study today.
The Federal Food, Drug, and Cosmetic Act specifies that print advertisements for prescription drugs and biological products are required to provide a true statement of information “in brief summary” about the advertised product’s “side effects, contraindications, and effectiveness.”
…Key findings of the studies include:
- Adding a serious risk did not hinder people’s understanding of the risk information.
- Including additional information about how often side effects occur and how long they may last did not hinder people’s understanding of the risk information.
- Participants who viewed the Drug Facts format were better able to recall risks than those who saw the traditional format.
+ Randomized Trial of Risk Information Formats in Direct-to-Consumer Prescription Drug Advertisements (abstract)
+ Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs
+ Questions and Answers
+ Study 3 Stimuli (PDF)
Background Document for Meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee
Background Document for Meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee
Source: U.S. Food and Drug Administration
In January, 2011, as part of a safety labeling change for all of the bisphosphonates approved for the treatment and/or prevention of osteoporosis, the following language was added to the Indications and Usage section of the product labels:
Important Limitations of Use
The safety and effectiveness of [drug] for the treatment of osteoporosis are based on clinical data of [xx] years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
Committee Members will be asked to discuss whether the available data support the long- term use of bisphosphonate medications for the treatment and/or prevention of osteoporosis and whether restricting the duration of use or implementing a drug holiday may be beneficial for patients with osteoporosis who require chronic long-term therapy.
From a safety perspective, the committee will be asked to discuss whether there is sufficient evidence to support an effect of long-term use of bisphosphonates therapy targeted at preventing and/or treating osteoporosis on the risk of developing osteonecrosis of the jaw, atypical fractures or esophageal cancer. Should the committee conclude there is a risk, they will be asked to discuss if there is sufficient evidence of an optimal duration of bisphosphonates use that would minimize these risks.
Committee Members will also be asked to discuss whether the available data support additional labeling changes.
FDA approves Botox to treat specific form of urinary incontinence
FDA approves Botox to treat specific form of urinary incontinence
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxinA) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder.
The treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity and a decrease in urinary incontinence.
“Urinary incontinence associated with neurologic conditions can be difficult to manage,” said George Benson, deputy director, Division of Reproductive and Urologic Products. “Botox offers another treatment option for these patients.”
FDA approves the first specific treatment for scorpion stings
FDA approves the first specific treatment for scorpion stings
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.
Venomous scorpions in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.
“This product provides a new treatment for children and adults and is designed specifically for scorpion stings,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Scorpion stings can be life-threatening, especially in infants and children.”
FDA, international counterparts report progress on drug inspection collaboration
FDA, international counterparts report progress on drug inspection collaboration
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration, together with its European and Australian counterparts, today released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.
The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials. Under the GCP pilot program, the FDA and the European Medicines Agency (EMA) exchanged more than 250 documents relating to 54 different drug products and, in conjunction with the GCP inspectors of the EU member states, organized 13 collaborative inspections of clinical trials. This lays the foundation for a more efficient use of limited resources, improved inspectional coverage, and better understanding of each agency’s inspection procedures. It demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals.
The report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM). Over the course of the 24 month pilot phase, the participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine collaborative inspections. The FDA used these reports to inform decisions, such as whether to postpone or expedite its own inspection. The FDA also prohibited imports into the U.S. of a firm’s products based on the negative findings from a European inspection. The information-sharing and collaborative inspections were important milestones in establishing a sense of mutual trust and common purpose among the drug regulatory agencies involved.
+ Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011 (PDF)
+ Final Report on the International API inspection Pilot Programme, May 2011 (PDF)
+ Frequently Asked Questions and Answers for the Report on the Pilot EMA-FDA GCP Initiative, September 2009 – March 2011 (PDF)
FDA Center for Drug Evaluation and Research develops strategic science and research agenda
FDA Center for Drug Evaluation and Research develops strategic science and research agenda
Source: U.S. Food and Drug Administration
A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and contributions to the development of agency regulatory science efforts.
“Communicating our science and research needs represents an important step in stimulating research and fostering collaborations with our external partners,” said CDER director Janet Woodcock, M.D. “We look forward to hearing from and working with our stakeholders.”
The report, “Identifying CDER’s Science and Research Needs Report,” identifies the following categories of science and research needs:
- Improve access to post-market data sources and explore feasibility of their use in different types of analyses
- Improve risk assessment and management strategies to reinforce the safe use of drugs
- Evaluate the effectiveness and impact of different types of regulatory communications to the public and other stakeholders
- Evaluate the link among product quality attributes, manufacturing processes and product performance
- Develop and improve predictive models of safety and efficacy in humans
- Improve clinical trial design, analysis and conduct
- Enhance individualization of patient treatment
