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    Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies

    Generic drugmakers submitting clinical studies on the adhesive performance of a transdermal delivery system (TDS) or topical patch will want to take note of new draft guidance released Tuesday from the US Food and Drug Administration (FDA). This guidance describes the recommended approach to an adhesion clinical study design used to support an abbreviated new drug application (ANDA) and, once finalized, the guidance will supersede FDA’s prior recommendations related to a...
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    Pediatric Study Plans: FDA Unveils Revised Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday released updated draft guidance intended to help pharmaceutical sponsors submit pediatric study plans, including what should be included in the plans and how they should be submitted. This revision, which FDA says was based largely on public comments, includes additional clarifications on the 2013 draft guidance, such as new information on what constitutes a materially incomplete initial pediatric study plan (iPSP), th...
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    RAPS Launches Global Survey of Regulatory Professionals' Work and Compensation

    RAPS has just launched its biennial global survey of regulatory professionals who work with healthcare and related products. RAPS’ Scope of Practice & Compensation Survey of the Regulatory Profession , conducted every two years, is the largest and most comprehensive survey of professionals in this important field, vital to ensuring healthcare products are safe and effective. Respondents work in the pharmaceutical, biotechnology and medical device industries, governme...
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    Congress Considers Priority Review Vouchers for Medical Countermeasures

    Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats. The recommendations are particularly timely as legislators and public health officials scramble to mount a response to the Zika virus outbreak across Latin America and the Caribbean. Many of these recommendations come from the Blue Ribbon Study Panel on ...
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    CDRH Develops 'Regulatory Toolkit' to Promote Device Innovation

    Officials from the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) say their efforts to develop a "regulatory toolkit" for sponsors has helped promote medical device innovation in the US, according to a recent viewpoint in JAMA Ophthalmology . While fostering innovation has been one of CDRH's strategic priorities since 2010, reports that growth in device clinical trials in the US had fallen behind other countries, including Braz...
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    What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding

    The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising. Background The study, announced in a 24 June 2015 posting in the Federal Register , is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug ad...
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    FDA to Study Effect of Generic Drug Appearance on Patient Adherence

    Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know. Background FDA has long been interested in the physical attributes of drugs, and in particular generic drug products. In December 2013, for example, it released a new guidance document, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules . In it, FDA explained tha...
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    How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out

    US regulators plan to launch a new study of medical device labeling in the hopes of determining if a standardized format could help healthcare providers to better understand the risks and benefits of a device prior to its use. Background If you purchase a pharmaceutical product in the US, you can be almost certain that the label on that product will look identical to every other drug product you've ever purchased. That's because the US Food and Drug Administration (FDA)...
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    FDA to Study Quality of Long-Acting Generic Drug Products, Including Popular Birth Control Drug

    The US Food and Drug Administration (FDA) is prepared to spend nearly a million dollars over the next two years to study the quality and effectiveness of long-acting generic drug products, including levonorgestrel-based birth control products, the agency announced last week. Overview The announcements, made on the National Institutes of Health's (NIH) website, relate to three separate study proposals focused on long-acting (LA) pharmaceutical products: Title Notice...
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    FDA Considers Allowing Drug Companies to Drop Some Warnings in TV Commercials

    The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them. Background The study, first proposed in February 2014, is meant to address a regulatory hypothesis: That consumers, bombarded with a long list of side effects, might have a difficult time deciding between drugs. In the s...
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    Conflicts of Interest on FDA's Advisory Committees Don't Matter Much, Paper Finds

    Conflicts of interest among members of the US Food and Drug Administration's (FDA) influential advisory committees don't have much of a practical impact on the outcome of voting decisions, new research argues. Background The paper comes as several research papers in recent years have made the opposite case—that advisory committee members with stated conflicts of interest do affect how a committee makes a decision. For example, a September 2014 paper in the journ...
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    Federal Commission Prepares to Weigh in on Ethics of Testing Ebola Treatments

    President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls. Are Placebos Ethical? The issue of placebo controls has been a contentious one to regulators and ethicists around the globe. At issue: Since Ebola has such a high rate of mortality, should all ...