Archive for April 2024

In a punishing one-two punch, the FDA slammed Zydus Lifesciences for the second time this month, with a 10-observation Form 483 finding — among other things — inadequately investigated glass particulate in injected drugs found in US markets and multiple deceptions about routine sample collection for contamination testing. Source: Drug Industry Daily

This edition of Quick Notes provides an overview of four recently released draft guidances on the manufacture of cell-based products and on the FDA’s enforcement policy regarding test manufacturers’ offering of certain unapproved tests during a future declared emergency or in the absence of such a declaration. Source: Drug Industry Daily

The FDA is soliciting written feedback as well as presenters to speak on its use of and processes for its advisory committee during a virtual listening session scheduled for June 13. Source: Drug Industry Daily

Big pharma again came out on the losing end of a major court battle challenging the Biden administration’s Inflation Reduction Act (IRA) drug price negotiations, as a New Jersey federal judge Monday rejected legal challenges from Bristol Myers Squibb and Johnson & Johnson. Source: Drug Industry Daily

In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final rule declaring that in vitro diagnostic products (IVD) manufactured in a laboratory are now considered medical devices, and thus under the regulation of the FDA. Source:…

In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced a final rule declaring that in vitro diagnostic products (IVD) are now considered medical devices, and thus under the regulation of the FDA. Source: Drug Industry Daily

Heightened regulation of mobile health apps and notification requirements for entities not covered under HIPAA are included in the final changes to the FTC’s Health Breach Notification Rule (HBNR) unveiled Friday. Source: Drug Industry Daily

From 2020-2021, more than 10 percent of globally manufactured active pharmaceutical ingredients (API) — 147 compounds — were linked to drug shortages in the US, according to a research letter published in JAMA Network. Source: Drug Industry Daily

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

A biopsy needle designed for use with a system that helps locate and diagnose brain tumors has been recalled by the manufacturer, Elekta Instrument AB, and is now deemed a Class I recall by the FDA for its potential for leaving microscopic steel debris in the brain. Source: Drug Industry Daily