On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more
8/9/2017
/ Biologics ,
Biosimilars ,
BsUFA ,
Diagnostic Imaging Services ,
Drug Pricing ,
FDA Reauthorization Act ,
FDARA ,
Food and Drug Administration (FDA) ,
GAO ,
GDUFA ,
Generic Drugs ,
Legislative Riders ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
National Evaluation System for Health Technology (NEST) ,
Over-the-Counter Sales ,
PDUFA ,
Pediatrics ,
Pending Legislation ,
Prescription Drugs ,
Supply Chain ,
User Fees
The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more
2/20/2015
/ Biologics ,
DQSA ,
Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Premarket Approval Applications ,
Prescription Drugs
July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more