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Lupin has been hit with a 10-observation Form 483 following an inspection of its Madhya Pradesh, India, drug manufacturing facility that revealed a failure to adequately handle out-of-specification results of batches that ended up on the U.S. market and remained there without “adequate justification.” Read More
The FDA has sent Champaklal Maganlal Homeo Pharmacy, located in Gujarat, India, a warning letter citing contamination issues after the agency’s Nov. 15, 2022, request for product testing records. Read More
The FDA handed APS Pharmacy a warning letter following the company’s response to a Form 483 that failed to address observations of the company’s compounding drug products using ineligible bulk drug substances. Read More
The FDA has issued a warning letter to Omega Packaging Corp. for failure to test active pharmaceutical ingredients for impurities and a lack of response from the company to this and other issues raised in a recent inspection. Read More
The number of priority review generics applications awaiting FDA action dropped by 25 percent in the first half of fiscal year 2023, signaling that the agency has improved review efficiency, according to a report published Tuesday. Read More
The FDA has adopted the International Council for Harmonization’s (ICH) revised guideline for quality risk management, releasing it in the form of a final agency guidance that advises pharma companies on risk management methodology, risk-based decision-making and managing subjectivity. Read More
Vanda Pharmaceuticals is suing the FDA, charging that the agency illegally revealed proprietary manufacturing information to companies seeking approval for generic forms of two of Vanda’s patented drugs. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
New digital technologies that enable clinical trials to take place in locations other than traditional trial sites are the subject of a long-awaited FDA draft guidance on conducting decentralized trials (DCT). Read More
A group of 26 state attorneys general joined the outcry against Medicare’s ongoing payment restrictions on antiamyloid antibody Alzheimer’s therapeutics, sending a letter to HHS last week calling for full coverage of the drugs. Read More