Documents

FDAOther

Citizen Petition from University of Illinois, College of Pharmacy

FDAOther

Citizen Petition from Katie Merkle

FDAOther

Hemodialysis Blood Tubing - Sets-Premarket-Notification (510(k)) Submissions; Guidance for Industry and FDA Staff

FDAOther

Forms FDA 3542a and FDA 3542: Questions and Answers; Guidance for Industry

FDAOther

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Guidance for Industry; Draft Guidance

FDANotice

Andrew Jonathan Morgan: Final Debarment Order

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committees

FDANPRM

Modification of Certain Terminology in Title 21

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals

FDARFI

Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information

FDAOther

Data Request (DR001): Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use