November 8, 2024

• VITAFER-L Gold 10ml may be harmful due to hidden drug ingredient
• VITAFER-L Gold 20ml may be harmful due to hidden drug ingredient
• VITAFER-L Gold 500ml may be harmful due to hidden drug ingredient
• PeakMax may be harmful due to hidden drug ingredients
• VitalityXtra may be harmful due to hidden drug ingredient
• ZapMax may be harmful due to hidden drug ingredients
• ZoomMax may be harmful due to hidden drug ingredients

November 7, 2024

• Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine

November 4, 2024

• Event: Generic Drugs Forum (GDF) 2025, April 9-10

November 1, 2024

• CDER Alert: FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness
• Upcoming Product-Specific Guidances for Generic Drug Product Development (Updated)
• Nhan Sam Tuyet Lien Truy Phong Hoan may be harmful due to hidden drug ingredients

October 30, 2024

• CDER Alert: Do not purchase or use Skin-Cap Aerosol Spray Products because they may be harmful to your health

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

November 8, 2024

• Reclassification (Updated)
• Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers (Updated)

November 7, 2024

• Breakthrough Devices Program (Updated)
• Presentation and Transcript added to Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - October 30, 2024
• Alternative Standards (MQSA): #25: Issuing a Report with the Assessment “Incomplete: Need additional imaging evaluation” in Follow-Up to an Initial Report with the Assessment “Incomplete: Need prior mammograms for comparison.”

November 6, 2024

• Updated Emergency Use Authorization
  • cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche Molecular Systems, Inc.)
• CDRH – A Great Place for Public Health Service Officers to Work

November 5, 2024

• Materials for November 7, 2024 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

November 4, 2024

• De Novo Decision Summaries (Updated):
  • DEN220024 - ScanNav Anatomy Peripheral Nerve Block
  • DEN210037 - SoClean 3+ Bacterial Reduction Device
  • DEN230046 - PGDx elio™ plasma focus Dx
  • DEN230067 - Germitee Chronos
  • DEN230069 - Mi-CHORD System
  • DEN230090 - First To Know Syphilis Test
• MedSun Newsletter - November 2024
• Explore Life at CDRH (Updated)
• MQSA National Statistics (Updates)

• 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 Rules Changes

Monday 4 November - NONE
Tuesday 5 November - NONE
Wednesday 6 November - NONE
Thursday 7 November - NONE
Friday 8 November - 21 CFR Part 80

NONE

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
&
Master Medical Device

Get Both Books! $49.95
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

 MOST POPULAR   DRUG GMPS   MEDICAL DEVICES   CLINICAL   BIOLOGICS   COSMETIC   UE-ICH-CAN-JPAL-NMPA   21 CFR PART 11