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    Looking to the Future in Regulatory Affairs

    Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and expectations, and discussions with peers in the regulatory community. There are many strands to consider when looking to the future in regulatory affairs. The first strand is the regulations and how these are likely to be impacted by a globalized ...
  • FDA Challenges Another Company's Interpretation of HCT/P Regulations, Leading to Delays

    On 6 September 2013, the US Food and Drug Administration (FDA) released an Untitled Letter to a manufacturer of amniotic/chorionic-based products, saying it had run afoul of "minimal manipulation" regulations under 21 CFR 1271. Now the company is in effect conceding to FDA's contentions, suspending enrollment in a US-based clinical trial meant to support an eventual regulatory filing and commercialization of its products. Background On 5 September 2013, FDA's Center for...
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    Perspectives on FDA Review of Medical Devices: Part 2

    The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews. Consider a Pre-Submission Meeting One particular strategy we have found quite productive, particularly for more-complex or innovative devices, is to...
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    Perspectives on FDA Review of Medical Devices: Part I

    In recent months, I have attended various medical conferences and trade shows that have highlighted many of the most promising med-tech innovations. From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. Yet, as a regulatory professional, I was struck by the numerous calls for the US Food and Drug Administration (FDA) reform and the claims FDA is st...
  • NICE Restricts GE's Diagnostic Test to Research Use

    General Electric (GE) Healthcare's diagnostic test (SeHCAT) for bile acid malabsorption in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and Crohn's disease without ileal resection has been restricted for research use by the National Health Service (NHS) according to  draft guidance  issued yesterday by the National Institute for Health and Clinical Excellence (NICE).  The draft recommends restricting SeHCAT to research settings in or...
  • Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional'

    A woman is suing the US Food and Drug Administration (FDA) over its policy requiring potential sperm donors to undergo health testing before being allowed to donate, calling the regulations a violation of her constitutional rights. At issue for the woman-an Oakland, California resident known only as "Jane Doe" in the court filings-is whether she can use a trusted male friend as a sperm donor so she may start a family with her female partner without the interference of th...
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    Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

    This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, 1-9 it discusses industry's response to FDA's proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and ...
  • FDA Releases New Guidance for Clinical Evaluation of Irritable Bowel Syndrome Drugs

    The US Food and Drug Administration (FDA) has released final guidance for industry to assist sponsors looking to develop drugs to treat patients suffering from irritable bowel syndrome (IBS). The 30 May guidance, Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment , covers general IBS symptoms and addresses two sub-sets of IBS which primarily result in diarrhea (IBS-D) and constipation (IBS-C), which FDA said have unique consi...
  • Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting

    The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve industry efficiency when conducting such trials. "The feedback may increase communication and collaboration within the stakeholder community, and, ultimately, help overcome some of the current challenges associated with designing clinical studies and generating clinical per...
  • FDA Warning Letter Cites Company for Breaking HCT/P Regulations

    A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...
  • Report: FDA Increasingly Playing Key Role in Global Health

    A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration's (FDA) effects are being felt far beyond US borders. The US health regulatory agency's statutory mandate is ostensibly to ensure the safety and effectiveness of products used by American consumers, but it is "increasingly…playing a role in global health R&D,...
  • For Terminally Ill Patients, 'Life Spans Shorter Than FDA's Approval Process' Spurs DIY Medicine

    Some terminally ill patients are turning research and development into a DIY enterprise, frustrated at the pace of getting potentially life-saving treatments through the US Food and Drug Administration (FDA), reports The Wall Street Journal . "We simply don't have time to wait for the results of [clinical trials]," said Ben Harris, who suffers from Lou Gehrig's Disease (ALS), to the Journal . "Our life spans are much shorter than the [Food and Drug Administration] appr...