October 17, 2024

• Draft Guidance: Postoperative Nausea and Vomiting: Developing Drugs for Prevention
• Generic Drugs Program Monthly and Quarterly Activities Report (Updated)
• Spotlight on CDER Science: Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets

October 15, 2024

• 7 Things to Know About Drug Shortage Management
• Accelerating Rare disease Cures (ARC) Program Year Two Annual Report

October 11, 2024

• Final Guidance: Temporary Policies for Compounding Certain Parenteral Drug Products
• Orange Book
  • Approved Drug Products with Therapeutic Equivalence Evaluations
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
    • Appendix A: Product Name Index (updated)
    • Appendix B: Product Name Sorted by Applicant (updated)
    • Appendix C: Uniform Terms (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)

• Drug Trials Snapshots: IZERVAY

October 10, 2024

• FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

October 9, 2024

• La FDA advierte a los consumidores de que no compren ni utilicen productos Umary y Amazy, ya que pueden ser perjudiciales para su salud
• Hurricane Helene: Baxter's manufacturing recovery in North Carolina
• Patent Certifications and Suitability Petitions

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

October 18, 2024

• Total Product Life Cycle Advisory Program (TAP) (Updated)
• Class I Recall: Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding
• Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle - 10/15/2024 (Updated)
  • Presentation External Link Disclaimer
  • Printable Slides
  • Transcript

October 17, 2024

• Class I Recall: Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life
• Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
  • Presentation External Link Disclaimer
  • Printable Slides
  • Transcript
• Federal Register: Accreditation Scheme for Conformity Assessment Program

October 16, 2024

• Ventilators and Ventilator Accessories EUAs (Updated)
• CDRH Petitions (Updated)

October 15, 2024

• Influenza Diagnostic Tests (Updated)
• Electronic Medical Devices, X-ray Imaging and Radiation Therapy: What to Know and How to Prevent Damage
• Device Trial Participation Snapshots
• De Novo Classification Order: DEN240029 - Healgen Rapid Check COVID-19/flu A&B Antigen Test
•  De Novo Decision Summaries (Updated):
  • DEN200076 - ORi
  • DEN210058 - ELEOSx™ Limb Salvage System
  • DEN220015 - Orthobond Mariner Pedicle Screw System
  • DEN220073 - Revi System
  • DEN230008 - DermaSensor
  • DEN230035 - DentalMonitoring
  • DEN230043 - Notal Vision Home Optical Coherence Tomography (OCT) System
  • DEN230081 - Hearing Aid Feature
  • DEN240013 - MagDI System

October 11, 2024

• Revoked Emergency Use Authorizations
  • Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health Inc.)
  • Cue COVID-19 Test (Cue Health Inc.)
• Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
• Safety and Performance Based Pathway (Updated)
• Class I Recall: Infusion Pump Recall: Zyno Medical Removes Certain Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients   
• Federal Register: Medical Devices: Quality System; Correction
• Federal Register: Endosseous Dental Implants and Endosseous Dental Implant Abutments -Performance Criteria for Safety and Performance Based Pathway

• 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

• Monday 14 October - NONE
• Tueday 15 October - 21 CFR Part 820 Quality Systems Regulations (QSR)
• Wednesday 16 October - NONE
• Thursday 17 October - NONE
• Friday 18 October - - 21 CFR Part 16

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

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