Federal Register notice: FDA withdraws its 2006 guidance entitled Exocrine Pancreatic Insufficiency Drug Products Submitting NDAs.
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Neurocrine Biosciences Ingrezza (valbenazine to...
Federal Register notice: FDA makes available a guidance entitled The Deemed To Be a License Provision of the BPCI Act: Questions and Answers.
Stericycle says drug and medical device manufacturers will likely see more government regulatory activity from FDA and other agencies in 2020.
FDA publishes a revised guidance on identifying and characterizing drug metabolites whose nonclinical toxicity needs to be evaluated.
FDA launches new PDUFA performance dashboards in its online performance management program.
Bipartisan legislation is introduced to speed lab test development and approval.
Federal Register notice: FDA announces the completion of the first phase of its enhanced Purple Book for biologics.