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The SEC is urging drugmakers to include details of FDA correspondence about products in 8-K disclosure filings, or to post portions of them on their websites, to make sure shareholder communications are accurate. Read More
The FDA will hold a June 5 public hearing at its White Oak, Md., campus to discuss FY 2016 regulatory science research priorities for generic drugs. Read More
The U.S. Court of Appeals for the Second Circuit Monday agreed to hear as soon as possible Actavis’ appeal of a lower court decision requiring it to keep an older formulation of its Alzheimer’s drug Namenda on shelves. Read More
Sponsors of clinical trials that rely on data from x-ray and other images should send those images to a centralized reading facility to prevent accidental unblinding or bias that may occur at trial sites, the FDA says. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued Tuesday by the Central Drugs Standard Control Organization. Read More
Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently. Read More
The FDA Tuesday ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone. Read More
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More
Chinese leaders want drugmakers to stop using third-party distributors and sell directly to hospitals in an effort to curb corruption in the supply chain. Read More
European regulators have granted Celgene’s nanotechnology-based therapy Abraxane its third cancer indication as a first-line treatment alongside carboplatin for non-small cell lung cancer patients who don’t qualify for surgery or radiation therapy. Read More