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The FDA has hit Actavis with a warning letter for making unsubstantiated claims about its Rapaflo benign prostatic hyperplasia drug on a company webpage. Read More
Johnson & Johnson will be liable for unlimited punitive damages in a bellwether trial next month alleging that Extra Strength Tylenol triggered acute liver failure leading to a woman’s death, under a federal court ruling. Read More
The FDA plans to issue a proposed rule this year streamlining requirements for fixed-dose combination prescription and over-the-counter drugs into one set of regulations, according to an updated list of priorities released Friday. Read More
California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday. Read More
To ensure data integrity, drugmakers should implement data controls in their manufacturing processes aligned with the risk to product quality, the Medicines and Healthcare products Regulatory Agency says. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in an April 13 citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
The majority of fixed-dose combination analgesics and antipsychotics on the Indian market have never been approved, leading to the sale of millions of doses of unsafe drugs, a new study concludes. Read More