December 27, 2024

• FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
• Draft Guidance: Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
• Draft Guidance: E6(R3) Good Clinical Practice: Annex 2
• Draft Guidance: M15 General Principles for Model-Informed Drug Development
• Final Guidance: E11A Pediatric Extrapolation

December 26, 2024

• Public Notifications:
  • Rhino 11 Gummy may be harmful due to hidden drug ingredient
  • Rhino Gummy Royal 50000 may be harmful due to hidden drug ingredient
  • Rhino 69 Gummy may be harmful due to hidden drug ingredient
  • Lucky Guy Platinum 18000 may be harmful due to hidden drug ingredient
• CDER Statement: FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder

December 23, 2024

• CDER Statement: FDA issues final rule to broaden types of nonprescription drugs available to consumers

December 20, 2024

• List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
• FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Dietary Supplements

Featured Links

• Dietary Supplement Guidance Documents
• Dietary Supplement Labeling Guide
• Small Entity Compliance Guide (cGMP)
• GRAS Notice Database
• Warning Letters

Applications & Submissions

• Certification Application Process (CAP) for Certificate of Free Sale (COFS) Applications
• New Dietary Ingredient (NDI) Notification
• Report an Adverse Event
• Food Facility Registration
• Small Business Nutrition Labeling Exemption
• Electronic Submission of Health Claim Petitions and Notifications 

Related Resources

• Redbook
• Qualified Health Claims
• Health Claims with Significant Scientific Agreement 
• Dietary Supplements: An Advertising Guide for Industry (FTC)
• FDA Basics for Industry

December 27, 2024

• Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments--Dermal Fillers
• Federal Register: Requests for Nominations: Individuals and Consumer Organizations for Advisory Committees
• Federal Register: Requests for Nominations: Patient Engagement Advisory Committee

December 23, 2024

• De Novo Reclassification Order(s):
  • DEN230027 - NaviCam ProScan
  • DEN240014 - ARCEX System
• De Novo Decision Summary:
  • DEN240014 - ARCEX System
• Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology (Updated)
• Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

December 20, 2024

• Clinical Decision Support Software Frequently Asked Questions (FAQs)
• Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (Updated)
• Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
• Class I Recall: Infusion Pump Battery Recall: ICU Medical Removes Some CSB Batteries Intended For Use With Plum 360, A+, and A+3 Infusion Systems Due to Reports of Allegedly Counterfeit, Untested Batteries In Use
• Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps - December 4, 2024
  • Presentation External Link Disclaimer
  • Transcript

• Biologics Guidances
• Biologics Procedures (SOPPs)
• Biologics Rules
• FDA Rules and Regulations
• Biosimilars
• Dockets Management
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Federal Register (FR) Notices
• Generic Drug User Fee Amendments
• Memoranda to Blood Establishments
• Biosimilar User Fee Amendments
• Medical Device User Fee Amendments (MDUFA)
• Prescription Drug User Fee Act (PDUFA)
• Food and Drug Administration Safety and Innovation Act (FDASIA)
• 21st Century Cures Act

Weekly Title 21 Rules Changes

Monday 23 December - NONE
Tuesday 24 December - NONE
Wednesday 25 December - NONE
Thursday 26 December - 21 CFR Parts 201 and 314
Friday 27 December - 21 CFR Part 101 Food Labeling

NONE

NONE

Drug Enforcement Administration (DEA)

Food and Drug Administration (FDA)

Tissue and Cell Key Resources

• Cord Blood Banking - Information for Consumers
  Ensuring the safety of cord blood for transplantation.
• Donor Eligibility Final Rule and Guidance Questions and Answers - ARCHIVED External Link Disclaimer
• Good Tissue Practice (CGTP) Final Rule Questions and Answers - ARCHIVED External Link Disclaimer
• Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling 6/19/2007 Final Rule Questions and Answers - ARCHIVED External Link Disclaimer
• Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling 
• Tissue and Tissue Product Questions and Answers

The International GMP
&
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over 2000 pages!

 GMP International Pharma. Master Reference Guide - 900+ pages of Guidance and Regulations

 GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745

GMP Manufacturing Handbook - GMP Manufacturing Handbook - Drug, Biologics, Vaccines & APIs -   Over 450 pages of Regulations and Guidance. Great for CMOs and GCP Industry

 21 CFR 210/211 - Drug GMPs - Add Parts 11 Electronic Systems and 820 QSR for Device - Click to View

 21 CFR 820 - Quality System Regulations - Include Audit Checklist with ISO 13485 References

 21 CFR 112 Produce for Human Consumption also in a combination English / Spanish

 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook

 21 CFR Part 117 - GMPs Hazard Analysis, and Risk-Based Preventive Controls for Food

 Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements

 Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements

 21 CFR Part 117 - GMPs Hazard Analysis, and Risk-Based Preventive Controls for Food

Don't see what you are looking for? Contact John Cuspilich, QA/RA, at jcuspilich@fda.com

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