[ Price : $8.95]
CDER Office of Compliance director Don Ashley tells a regulatory conference that the Center is planning a guidance document on the...[ Price : $8.95]
FDA denies a Braintree citizen petition that asked it not to approve a tablet-based or tablet-containing colonoscopy preparation u...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Policy for Monkeypox Tests To Address the Public Health Eme...[ Price : $8.95]
Federal Register notice: FDA announces an 11/18 joint advisory committee meeting to discuss a Laboratoire HRA Pharma supplemental ...[ Price : $8.95]
Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for com...[ Price : $8.95]
FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency say...[ Price : $8.95]
FDA approves a Bristol Myers Squibb NDA for plaque psoriasis drug Sotyktu (deucravacitinib), a first-in-class, oral, selective, al...[ Price : $8.95]
BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene...