The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and…

The FDA published a new manual of policies and procedures for reviewing staff, detailing how the agency will communicate ANDA deficiencies with applicants — meeting one of its first commitments…

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treatment with certain anticancer drugs to keep the drugs from harming an embryo or fetus, the FDA recommended in draft guidance.…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…

The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to…

A Chinese maker of pain-relief balms and ointments falsified results of tests on its products and deflected FDA inspectors seeking to examine its laboratory, the FDA said in a warning…

A federal judge ruled Purdue Pharma must face most of the claims in a lawsuit filed against the drugmaker by a Washington city earlier this year. Source: Drug Industry Daily

The PTO’s Patent Trial and Appeals Board invalidated Aventis Pharma’s patent for the chemotherapy drug Jevtana (cabazitaxel), following a challenge from Mylan. Source: Drug Industry Daily