Federal Register
Animal Drug User Fee Reauthorization Public Meeting
Federal Register notice: FDA announces a 11/2 public meeting entitled Animal Drug User Fee Act.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 10/6/2017.
Federal Register
Regulatory Review Period Determined for Bayers Kovaltry
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Bayers Kovaltry (antihemophilic factor (recombi...
Human Drugs
FDA Approves Flexion NDA for Knee Pain
FDA approves a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-arti...
Medical Devices
Sens. Warren, Grassley Call for Device Identifiers on Claims Forms
Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) call for medical device identifier information be added to Medicare claims in order to bett...
Human Drugs
FDA Approves Flexion NDA for Knee Pain
FDA approves a Flexion Therapeutics NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-arti...
Human Drugs
Regulatory Review Period for Biogen Idecs Tecfidera
Federal Register notice: FDA has determined the regulatory review period for patent restoration purposes for Biogen Idecs Tecfidera (dimethyl fumarate...
Human Drugs
Baxter Recalls Intralipid Lot Due to Subfreezing Storage
Baxter International recalls one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100 mL, after it was exposed to subfreezing temperature...
Human Drugs
Policy on Providing ANDA Review Status Updates to Sponsors
CDER publishes a new Manual of Policies and Procedures (MAPP 5200.12) on Communicating Abbreviated New Drug Application Review Status Updates with Ind...
