Workshop on Devices to Treat Metabolic Diseases
09/13/2013
Guidance on Bioanalytical Method Validation
09/13/2013
Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioanalytical Method Validation. It is int...
Info on Postmarket Surveillance Sent to OMB
09/11/2013
Comments Sought on Symbols on IVD Labels
09/11/2013
Info on Youth Tobacco Campaigns Sent to OMB
09/11/2013
Workshop on Clinical Trials and FDA Interaction
09/11/2013
FDA Extends Comments on Cigarette/Menthol Regulation
09/11/2013
Federal Register Advance notice of proposed rulemaking: FDA is extending the comment period for a 7/24 advance notice of proposed ...
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Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...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 ...
