FDA warns Clinicon about Quality System violations in its manufacturing of SureProbe laser accessory probes.
CDER issues a MAPP on policies and procedures for FDA Amendments Act safety labeling changes.
The Tufts Center for the Study of Drug Development reports that drug development targeting rare diseases is one of the fastest growing and one of the ...
FDA warns three API repackers about violations of current good manufacturing practice regulations.
FDA issues an immediate effect guidance explaining when it will exercise enforcement discretion for licensed pharmacists and doctors who use bulk oxit...
FDA issues a draft guidance with recommendations for applicants to use in writing the Drug Abuse and Dependence section of labeling for human prescrip...
FDA issues a draft guidance with recommendations for developing content and format of an Instructions for Use document for certain prescription drugs ...
Federal Register notice: FDA makes available a final guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifes...