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. Source: Drug…
FDA Commissioner Robert Califf wants to push the agency toward approving AI assisted medical devices that contain algorithms capable of learning, adapting and changing as they gather and analyze 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…
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…
BD has announced a settlement in the class action lawsuit related to its Alaris infusion pumps, agreeing to pay $85 million to resolve all the claims against the company and…
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…
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…
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…
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. Source: Drug Industry…
The integration of AI tools like ChatGPT and GitHub Copilot into corporate structures can revolutionize efficiency and productivity, especially in software development and content generation. Source: Drug Industry Daily