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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 Patient Counseling Section for Drug/Biologic Labels

09/18/2013

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioanalytical Method Validation.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 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

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