FDA Withdraws Guide on Frozen Plasma
07/22/2013
Federal Register Notice: FDA is withdrawing a compliance policy guide entitled “Sec. 253.100 — Use of Units of Plasma ...
Public Meeting on Narcolepsy Drug Development
07/19/2013
FDA Withdraws NDAs, ANDAs
07/19/2013
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Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...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
Guidance on Product Design Safety Considerations
12/13/2012
