FDA Sets Generic API, Finished Dosage Form Facilities Fees
01/17/2013
Federal Register Notice: FDA is announcing the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) ...
FDA Proposes to Reclassify Membrane Lung Devices
01/08/2013
FDA Proposes to Reclassify External Cardiac Compressor
01/08/2013
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Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...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
