Notices

Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program

Notices

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)

Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information

High-Protein Yogurt; Request for Information

Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications

Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications

Rules and Regulations

Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs

Proposed Rules

Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products

Food Labeling: Front-of-Package Nutrition Information

Notices

Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; Availability

Proposal to Refuse to Approve a New Drug Application for TRADIPITANT; Opportunity for a Hearing

Use of Cannabis-Derived Products, Including Cannabidiol, in Veterinary Practice; Request for Information

Rules and Regulations

Expansion of Buprenorphine Treatment via Telemedicine Encounter

Continuity of Care via Telemedicine for Veterans Affairs Patients

Rules and Regulations

Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal

Listing of Color Additives Exempt From Certification; Myoglobin

Notices

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting

Agency Information Collection Activities; Proposed Collection; Improving the Quality and Representativeness of the Treatment Center Program Data-Data Modifications to the Current Survey Instrument Format to Minimize Misclassification; Withdrawal of Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Establishment Registration and Listing

Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments

Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology; Draft Guidance for Industry; Availability

Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period

Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development; Public Workshop; Request for Comments

Optimizing Pregnancy Registries; Public Workshop

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