Rules and Regulations - 21 CFR Part 1308 Controlled Substance (DEA)

Schedules of Controlled Substances: Extension of Temporary Placement of Seven Specific Fentanyl-Related Substances in Schedule I of the Controlled Substances Act

Notices

Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; National Agriculture and Food Defense Strategy Survey

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collection

M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability

E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry; Availability

E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Availability

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments-Dermal Fillers

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Application 218276 S-004 for FABHALTA (iptacopan) Oral Capsules in the Treatment of Adults With C3G

Determination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGE

Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH

Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN

Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER

Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee

Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches

Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction

Rules and Regulations - 21 CFR Part 101 Food Labeling (Not a Rule Change)

Uniform Compliance Date for Food Labeling Regulations

Notices

Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Period

Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal

Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications

Notices

Advanced Manufacturing Technologies Designation Program; Guidance for Industry; Availability

Liquid Eggs Deviating From the Standard of Identity; Revocation of Temporary Permit for Market Testing

Notices

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act

Standard Sterile Product
Manufacturing Handbook

Sterile Drug MFG Handbooks - SAVE 15%

- 21 CFR Part 11 with Scope and Application
- Part 210/211 GMPs
- ICH Q7 API GMPs
- EU GMPs Annex 1 Sterile Drug 2023