FDA approves a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing arteriovenous access i...
Three major pharmaceutical sector stakeholders say an analysis they commissioned shows that the number of new medicines would drop sharply in the next...
CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD format.
The World Health Organization releases for comment a draft guideline on a risk-based approach to data integrity.
FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on information to includ...
Federal Register notice: FDA establishes a public docket for interested parties to nominate bulk drug substances or re-nominate bulk drug substances t...
Federal Register notice: FDA makes available a draft guidance for Industry #256 entitled Compounding Animal Drugs from Bulk Drug Substances.
CDRHer Joshua Chetta outlines provisions in a draft guidance proposing the new Safer Technology Program for Medical Devices.