Archived documents

Food Additive Petition seeking amended food additive regulations to remove FDA's approval of four carcinogenic solvents

Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.

Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies

Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry

PSG_020076 - Draft Guidance on Nicotine

Determination That SERZONE (Nefazodone Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", also download published version into the folder.

Determination That DIAZEPAM Injection United States Pharmacopeia (5 Milligrams/Milliliter in a 1- Milliliter Container) Was not Withdrawn From Sale for Reasons of Safety or Effectiveness

Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Letter from FDA CDER to Lachman Consultant Services, Inc.

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE

Color Additive Petition submitted seeking amended color additive regulations to remove FDA's approval of three carcinogenic solvents