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The European Medicines Agency’s EudraVigilance system for monitoring adverse events is undergoing an overhaul to comply with new postmarketing clinical trials legislation, and regulators are readying drugmakers and national authorities for a new plan. Read More
Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
Drugmakers are telling the FDA that its proposed biosimilars naming is not necessary, but if four-letter suffixes are needed in the nonproprietary naming of biosimiliars and other biologic products, then make sure those letters are memorable. Read More
The FDA handed SSM Health Care a warning letter for GMP deficiencies in compounding sterile drug products as well as failure to follow 503B conditions for outsourcing facilities at its Fenton, Mo., facility. Read More
Novartis has agreed to pay a tentative settlement of $390 million in a whistleblower’s lawsuit alleging the company received kickbacks from pharmacies to promote products, ending a four-year-old case. Read More
The FDA’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More
Shire to Resubmit Lifitegrast NDA With New Data GSK’s Shingles Vaccine Meets Primary Endpoint in Phase III Trial Amgen, GSK Heart Failure Drug Candidates Show Markedly Different Results Senators Ask FTC to Investigate Saline Solution GSK China Plant Loses UK GMP Certificate FDA Panel Declines to Add Substances to List for Use in Compounding Sun Pharma Recalls Over 1 Million Boxes of Loratadine Read More
Drugmakers won a victory on Monday when the Senate approved by unanimous consent an amended bill that would extend exclusivity periods for new drugs by changing the date on which they are considered to have been approved from FDA sign-off to when the DEA schedules them. Read More