Rules and Regulations - 21 CFR Part 211 (Not a Rule Change)

Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability

Notices

Food Contact Notifications That Are No Longer Effective

Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee

Proposed Rules

Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability

Notices

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry; Availability

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry; Availability

Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

Food and Drug Administration Animal Food Ingredient Consultation; Guidance for Industry; Availability

Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability

Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability

Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request

Pulse Oximeters for Medical Purposes-Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Heritable Intentional Genomic Alterations in Animals: The Approval Process; Guidance for Industry; Availability

Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request

Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Guidance for Industry; Availability

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Interested Parties; Availability

Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant Communicable Disease Agents and Diseases by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability

Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability

Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability

Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards; Availability

Notices

Withdrawal of Food and Drug Administration Notice Regarding Yong Sheng Jiao; Denial of Hearing; Final Debarment Order

Yong Sheng Jiao; Denial of Hearing; Final Debarment Order

Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability

Developing Drugs for Optical Imaging; Draft Guidance for Industry; Availability

Notices

National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments

Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor)

Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont)

Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee

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