FDA, CMS Extend Parallel Review Pilot
12/18/2013
Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services have decided to extend the “Pilot Program fo...
Guidance on BE Studies for ANDA Pharmacokinetic Endpoints
12/05/2013
Guidance on BE Recommendations on Paliperidone Palmitate
12/05/2013
FDA Sends OTC Drug Labeling Info to OMB
12/05/2013
Federal Register Notice: FDA proposed collection of information, “Over-the-Counter Drugs; Labeling Requirements,” has ...
Guidance on Certification for Medical Gases
12/18/2012
Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...
Guidance on Enrichment Strategies in Trials for NDAs, BLAs
12/17/2012
Comments Sought on HDE Applications
12/17/2012
Federal Register Notice: FDA is seeking public comment on information to accompany humanitarian device exemption applications and ...
Guide on RFID Studies is Extended
12/17/2012
Info on Tobacco Industry Meeting Guidance Sent to OMB
12/13/2012
Guidance Out on Design Considerations for Home Use Devices
12/13/2012
