[ Price : $8.95]
FDA clears an Expanding Orthopedics 510(k) for the FLXfit 15 3D Expandable Cage System for restoring lumbar lordosis while control...[ Price : $8.95]
FDA commissioner Scott Gottlieb outlines additional steps the agency is taking to try to cut overall exposure to opioids.[ Price : $8.95]
FDA publishes a draft guidance on reproductive toxicity assessments for anti-cancer drugs.[ Price : $8.95]
CDER issues a MAPP for ANDA filing reviewers on the procedure for communicating with applicants about submissions that contain min...[ Price : $8.95]
FDA launches a new search tool to improve access to data on drug and biologic adverse events through its Adverse Event Reporting S...[ Price : $8.95]
FDA releases a FDA-483 issued to a Dr. Reddys drug manufacturing facility in the UK.[ Price : $8.95]
CDER publishes a MAPP on procedures and responsibilities for Office of New Drug completion and processing of annual status reports...[ Price : $8.95]
FDA releases two documents and plans more steps to help drug compounders register as outsourcing facilities.