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The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs). Read More
The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read More
The physician previously pled guilty to 14 counts of illegal distribution of controlled substances in a related criminal case and is expected to be sentenced in January 2020.
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The DEA said that 27 percent of sampled tablets it seized nationwide between January and March 2019 contained potentially lethal doses of fentanyl. Read More
The House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill on Wednesday aimed at ending the abuse of citizen petitions to stall generic approvals. Read More
Teva Pharmaceuticals has been hit with a patent infringement suit in a Delaware district court by Switzerland-based Ibsa Pharmaceuticals and Altergon over its generic version of Ibsa’s hypothyroidism treatment Tirosint (levothyroxine). Read More
An FDA advisory committee voted on Wednesday to turn down Boehringer Ingelheim’s empagliflozin oral tablets in 2.5 mg doses for type 1 diabetes. Read More