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A contaminated water system at one of Torrent Pharmaceuticals’ U.S. manufacturing facilities — and inadequate investigations into failing microbiological results — resulted in a second FDA warning letter for the company in a single month. Read More
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance released Wednesday. Read More
The FDA published its fall regulatory agenda on Wednesday for upcoming proposed and final rulemakings, including the following planned actions: Read More
In his mostly smooth Senate confirmation hearing on Wednesday, the administration’s nominee for FDA commissioner said there are some indirect actions the FDA could take to lower drug prices, although he demurred on giving a direct example. Read More
The FDA hit Japanese API and sterile drug manufacturer Shionogi with a Form 483 for deficiencies in its production batch records and cleaning procedures. Read More
Apothecus Pharmaceutical drew a warning letter from the FDA for quality and data integrity violations at its manufacturing facility in Hicksville, New York. Read More
The U.S. Patent Trials and Appeals Board has agreed to launch an inter partes review of a GlaxoSmithKline patent aimed at a vaccine component. Read More
The House Judiciary Committee is set to mark up two pieces of bipartisan legislation today that aim to crack down on drugmakers who game the patent system. Read More