OMB OKs Info on Informed Consent for IVD Device Studies
05/10/2013
Comments Sought on Authorized Generic Drugs Reporting
05/10/2013
Federal Register Notice: FDA is seeking comments on the information collection contained in the requirements for reporting informa...
Panel to Discuss Organon NDA for Neuromuscular Blockade
05/10/2013
Comments Sought on PDUFA Workload Adjuster
05/07/2013
Federal Register Notice: FDA is seeking public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adj...
Comments Sought on Health Risk Concerns Sent to CDRH
05/07/2013
Federal Register Notice: FDA is seeking public comment on information voluntarily submitted to CDRH on actual or potential health ...
Conference on Pharmaceutical Quality Systems
05/07/2013
Federal Register Notice: FDA and the International Society of Pharmaceutical Engineering will co-sponsor a conference entitled &ld...
Comments Sought Clinical Trial Subject Protection
04/24/2013
Federal Register Notice: FDA is seeking public comment on a proposed collection of information on the regulations that provide pro...
Guidance on Safety Considerations for Container Labeling
04/24/2013
FDA Withdraws Oxycontin NDA
04/18/2013
Federal Register Notice: FDA has determined that Oxycontin (oxycodone hydrochloride) extended-release tablets (10, 15, 20, 30, 40,...
No Furloughs, But Other Cuts Under Sequester: Hamburg
04/18/2013
FDA commissioner Margaret Hamburg told Senate appropriators 4/18 that no furloughs are expected at the agency as a result of the $...
