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The FDA issued 35 new draft and 22 revised product-specific guidances for generic drugs, including the pain treatment buprenorphine, the skin disorder treatment fluocinonide and the multiple myeloma drug ixazomib citrate. Read More
Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance. Read More
A group of non-profits and activist organizations, including the American Lung Association, National Health Council and National Organization for Rare Disorders, urged lawmakers in the House of Representatives not to pass proposed right-to-try legislation. Read More
The FDA released new information for ANDA applicants on when to submit elemental impurity data, and acknowledged that new guidelines on reporting elemental impurities had slowed approvals in January. Read More