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In two recently issued documents, the FDA tackled methods for requesting reconsideration of an ANDA decision and provided final guidance on evaluating the viral safety of biotechnology products. Read More
During a virtual town hall Wednesday, FDA staff divulged there are currently no fully adequate substitutes for ethylene oxide (EtO), a chemical used to sterilize half of all medical devices in the U.S., and which can also cause an increased risk of various cancers. Read More
There’s been a rising concern with clinical trial fraud and misconduct, particularly over the number of “zombie” trials that have been discovered in recent years — that is, trials in which a portion of the data is either invented out of whole cloth or is manipulated to the point of dishonesty. Read More
In response to an FDA warning letter about its placental-derived tissue product Axiofill, MiMedx Group defended its position that Axiofill is not a biologic drug and therefore not subject to additional oversight. Read More
The FDA approved 55 novel drugs and five biosimilars last year — substantially more than the 36 approved in 2022, according to the agency’s year-end report, but similar to the numbers approved in prior years. Read More
Sen. Bernie Sanders (I-Vt.), chair of the Senate Committee on Health, Education, Labor and Pensions (HELP), along with Democrats on the committee, has launched an investigation into the high price of asthma inhalers in the U.S., targeting four makers of the devices — AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK) and Teva Pharmaceuticals. Read More
This edition of Quick Notes looks at recent FDA Class I and company recalls involving patient return electrodes, pump-incompatible syringes, unintentional double drug dosing and missing zeroes. Read More
Boston Scientific, GSK and Johnson & Johnson have each announced billion dollar acquisitions this week with major deals designed to expand the companies’ portfolios in very specific areas. Read More
The FDA launched a new search function on its website, designed to help users search for pharmaceutical quality-related guidances, compliance programs and manuals of policies and procedures (MAPP). Read More