November 15, 2024

• FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation
• Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA

November 13, 2024

• Flurbiprofen Tablet (Discontinuation)
• Isosorbide Mononitrate Tablet (Discontinuation)

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

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 15, 2024

• Consumer Information: GORE EXCLUDER Conformable AAA Endoprostheses (EXCC) - P200030/S014 (W.L. Gore & Associates, Inc.)
• Consumer Information: TruSight Oncology Comprehensive - P230011 (Illumina, Inc)
• Consumer Information: Simplera system - P160007/S047 (Medtronic MiniMed, Inc.)
• Consumer Information: UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System - P230012 (Alcon Research, LLC)
• Class I Recall: Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel
• Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers
• Medical Device Shortages List (Updated)
• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - November 20, 2024
• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)

November 14, 2024

• Blood Glucose Monitoring Devices (Updated)
• De Novo Decision Summaries (Updated):
  • DEN230092 - Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack & Sample Prep Kit
  • DEN230011 - OcuCool
  • DEN240016 - Xpert HCV; GeneXpert Xpress System
  • DEN220030 - RemeOs™ Screw LAG Solid
  • DEN240007 - BioHealx Anal Fistula Device
• De Novo Classification Order:
  • DEN230082 - Stone Clear
  • DEN230083 - Valeda Light Delivery System
  • DEN230084 - Dexter L6 Surgical System

November 12, 2024

• Updated Emergency Use Authorization
  • ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices (DNA Genotek Inc.)

November 8, 2024

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

• 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 11 November - NONE
Tuesday 12 November - NONE
Wednesday 13 November - NONE
Thursday 14 November - NONE
Friday 15 November - 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
&
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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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