Drugmakers wishing to use emerging manufacturing technology should ask to participate in an FDA program designed to help them through the approval process for new medicines, the agency said in…

An FDA advisory committee voted 10 to 1 Wednesday that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective. Source: Drug Industry Daily

Women should avoid pregnancy for six months after ending treatment with certain anticancer drugs to keep the drugs from harming an embryo or fetus, the FDA recommended in draft guidance.…

Manufacturers of short-acting opioids will be required to offer the kind of doctor training in administering the medications that their extended-release counterparts have been directed to provide since 2012, FDA…