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In a proposed rule, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that were modified or delayed due to COVID-19. Read More
Sanofi and GlaxoSmithKline announced in Security Exchange Commission (SEC) filings that the Department of Justice and the U.S. Attorney’s Office for the Eastern District of Pennsylvania have opened an investigation into their reporting of potentially contaminated Zantac (ranitidine). Read More
The European Medicines Agency (EMA) has updated its advice on impurity testing for nitrosamines, expanding it to include some biological medicines. Read More
The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Read More
Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said in its latest annual report. Read More
The European Medicines Agency’s suspended the marketing authorizations of generic drugs tested by Panexcell Clinical Laboratories at its site in Mumbai, India. Read More
A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Read More
A Mylan Laboratories active pharmaceutical ingredient (API) manufacturing facility in India drew a warning letter from the FDA for cleaning and other failures. Read More
The FDA hit Las Vegas compounder ACRx Specialty Pharmacy for poor aseptic practices and other GMP failures observed during an inspection last year. Read More
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Read More