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Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioanalytical Method Validation.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 Non-Clinical Testing for Intravascular Stents
08/30/2013
Federal Register Notice: FDA is making available a draft guidance entitled Select Updates for Non-Clinical Engineering Tests and R...
Info on Submitting Info to CVM with e-Submission Gateway
08/30/2013
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry 108 on How To Submit Informa...
Guidance on BE Studies for Risperidone
08/26/2013
Federal Register Notice: FDA is making available a revised draft guidance for industry entitled Draft Guidance on Risperidone. It ...
FDA Posts Final eCTD Specification Documents
08/26/2013
Federal Register Notice: FDA is making available on its Web site revised final versions of the following four documents that suppo...
