Guidance on Electronic Source Data in Clinical Trials
09/18/2013
Federal Register Notice: FDA is making available a guidance for industry entitled Electronic Source Data in Clinical Investigation...
Public Hearing on Emergency Eye Wash Products
09/18/2013
Federal Register Notice: FDA will hold a public hearing 12/4 on currently marketed OTC emergency first aid eye wash drug products ...
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Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioanalytical Method Validation.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 Electronic Labeling for Drugs, Biologics Sent to OMB
09/13/2013
Federal Register Notice: FDA’s proposed collection of information, “Requirements for Submission of Labeling for Human ...
Workshop on Devices to Treat Metabolic Diseases
09/13/2013
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 ...
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
