Documents

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements

FDANPRM

Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

FDANotice

Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation Scheme for Conformity Assessment Program

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Voluntary Improvement Program

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards

FDARFI

Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notifications Submission

FDANPRM

Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges