Agency Information Collection Activities; Announcement of OMB Approval; MedWatch: The FDA Medical Products Reporting
Program. (06MAY01) Click here for txt
or
pdf Prepublication display Supporting Statement
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited Safety
Reports; Availability. (04MAY01)
Click here for txt or pdf Prepublication display The Guidance
Agency Information Collection Activities; Announcement of OMB Approval; Adverse Experience Reporting for Licensed
Biological Products and General Records.
(01MAY01) Click here for txt or pdf Prepublication display Supporting Statement
Studies of Adverse Effects of Marketed Drugs; Availability of Grants (Cooperative Agreements); (04APR01) Click here for
txt or pdf Prepublication display
CDER 2000157. Draft Guidance for Industry on Postmarketing Safety Reporting for Human Drug and Biological Products
Including Vaccines; Availability. (12MAR01) Click here for txt or pdf Prepublication display The Draft Guidance
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical
Devices and Blood Products. (08FEB01) Click here for
txt or pdf
Prepublication display
