November 22, 2024

• THERMO SHOCK may be harmful due to hidden ingredients
• Force Forever may be harmful due to hidden drug ingredients
• FDA Drug Topics: An Update onTransmucosal Buprenorphine and Dental Caries - December 10, 2024

November 21, 2024

• Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805 (updated)
• FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer

November 19, 2024

• SBIA Webinar: BsUFA III Regulatory Science Pilot Program: Program Updates
• From Our Perspective: OMUFA – Past, Current, and Future
• HON-E-LING may be harmful due to hidden drug ingredients
• Drug Trials Snapshots: VAFSEO

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

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 22, 2024

• CDRH Petitions (Updated)

November 21, 2024

• Standards Newsletter from the Division of Standards and Conformity Assessment External Link Disclaimer
• Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Guidance for Industry and Food and Drug Administration Staff
• Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
• CDRH Announces Communications Pilot to Enhance Medical Device Recall Program
• Federal Register: Guidance: Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket Notification (510(k)) Submissions

November 20, 2024

• 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
• Federal Register: Guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization Review

November 19, 2024

• Class I Recall: 
  • Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge  
  • Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2, due to Risk of Inaccurate Flow Measurements Caused by Certain In-Line Nebulizer Placements
  • Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure
• Medical Device Development Tools (MDDT)  - Summary of Evidence and Basis of Qualification For WOUND-Q
• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A - November 20, 2024
  • Printable Slides
• Revised Emergency Use Authorizations
  • NxTAG Respiratory Pathogen Panel + SARS-CoV-2 03/03/2021 (Luminex Molecular Diagnostics, Inc.)
  • Nano-Check Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
• Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Revocation

November 18, 2024

• Agenda and Roster for November 20-21, 2024 Digital Health Advisory Committee Meeting
• De Novo Decision Summaries (Updated):
  • DEN230052 - Eversense AP CGM System
  • DEN240029 - Healgen Rapid Check COVID-19/Flu A & B Antigen Test
• At-Home OTC COVID-19 Diagnostic Tests (Updated)
• Revised Emergency Use Authorizations
  • ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test (Princeton BioMeditech Corp.)

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)

• 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 18 November - NONE
Tuesday 19 November - - 21 CFR Part 1307 (DEA)
Wednesday 20 November - NONE
Thursday 21 November - NONE
Friday 22 November - NONE

Drug Enforcement Administration (DEA)

Food and Drug Administration (FDA)

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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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

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