On November 8, 2016, FDA announced a final rule (81 FR 78500) amending citizen petition regulations (21 CFR 10). The new rule is meant to ensure the agency does not delay the approval of a pending ANDA, 505(b)(2) or biosimilar application filed under section 351(k) of the PHS Act, unless that delay is necessary to…
DetailsIn advance of FDA’s Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products (October 31 – November 1, 2016), FDA Voice published Key Facts about Abuse-Deterrent Opioids, by Douglas C. Throckmorton, M.D. In his article, Throckmorton reminds us that “It’s important to recognize that FDA refers to these drugs as ‘abuse-deterrent’ not…
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What is a Combination Product? In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of today’s fastest growing medical product segments are combination products. To be considered a combination product by FDA, there must be two or…
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Drug holidays are not often described in the U.S. professional labeling of prescription drug products. However, they are routinely employed across various classes of drugs as well as a variety of patient populations. As the name implies, a drug holiday is the temporary suspension of active therapy[1], and is usually enacted to avoid adverse events…
DetailsOn October 17, 2016, FDA announced “that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic and international…
DetailsFollowing is an excerpt from the Executive Summary (Click here for the Final Rule; 81 FR 69580) “Title XI of the MMA addressed two key concerns identified in a Federal Trade Commission (FTC) report on anticompetitive strategies that may delay access to generic drugs by: (1) Limiting the availability of 30-month stays of approval on…
Details“To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.” On…
DetailsFDA has released a new draft guidance “intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more closely in time. The draft guidance is intended to address concerns that new FDA-approved…
DetailsOctober 3-5, 2016: Nobel Prizes in Physics, Chemistry and Physiology Announced • Physics 2016: David J. Thouless, F. Duncan M. Haldane and J. Michael Kosterlitz for “theoretical discoveries of topological phase transitions and topological phases of matter” • Chemistry: Jean-Pierre Sauvage, Sir J. Fraser Stoddart and Bernard L. Feringa “for the design and synthesis of…
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What is a Quality Management System (QMS)? As a marketer or manufacturer of medical devices, you know that a quality management system (QMS) is critical to your success and continued operation. It doesn’t take more than one FDA inspection to figure this one out. If you are involved in, or considering entry into the medical…
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