Agency Information Collection Activities; Submission for OMB Review; Comment Request; Adverse Experience Reporting for
Licensed Biological Products, and General Records. (26DEC00) Click here for txt or pdf Prepublication display |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidance on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) (VICH GL24); Availability; Request of Comments. (18DEC00) Click here for txt
or
pdf Prepublication display
Draft Guidance |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; MedWatch: The FDA Medical Products
Reporting Program. (16NOV00) Click here for txt or pdf
Prepublication display |
Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed
Biological Products; and General Records. (25SEP00) Click here for txt or pdf Prepublication document |
Postmarket Surveillance. (29AUG00) Click here for txt or pdf Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: FDA's Medical Product Reporting
Program. (26JUL00) Click here for txt or pdf Prepublication document |
Draft Guidance for Industry on the Content and Format of the Adverse Reactions Section of Labeling for Human Prescription
Drugs and Biologics; Availability. (21JUN00) Click here for
txt or pdf Prepublication document The Draft Guidance |
Medwatch/MDR/FDA Website Navigation; Public Meeting. (13MAR00) Click here for txt
or pdf Prepublication document |