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Recent news from the US Food and Drug Administration.
Click title to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom. Press announcements from 2004 to 2009 are available through
the FDA
Archive.
FDA
Recalls: FDA posts press releases and other notices of recalls and
market withdrawals from the firms involved as a service to consumers,
the media, and other interested parties. FDA does not endorse either the
product or the company. This site does not contain a complete list of
recalls -
search for recalls at the official FDA site.
| September 30, 2025 - FDA
Conditionally Approves First Drug for Prevention and Treatment of
New World Screwworm Infestations in Cattle |
| September 30, 2025 - A
Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging
Retailers to Stop Selling Illegal Vapes |
| September 25, 2025 - FDA
Authorizes Marketing of First Eyeglass Lenses to Slow Progression
of Pediatric Myopia |
| September 25, 2025 - FDA
Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa
(vandetanib) |
| September 22, 2025 - FDA
Responds to Evidence of Possible Association Between Autism and Acetaminophen
Use During Pregnancy |
| September 22, 2025 - FDA
Takes Action to Make a Treatment Available for Autism Symptoms |
| September 19, 2025 - FDA
Grants Accelerated Approval to First Treatment for Barth Syndrome
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| September 12, 2025 - FDA
Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic
Products |
| September 10, 2025 - HHS,
CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever
Operation |
| September 10, 2025 - FDA
Issues New Guidance to Expand Non-Opioid Options for Chronic Pain,
Curb Misuse |
| September 9, 2025 - FDA
Launches Crackdown on Deceptive Drug Advertising |
| September 5, 2025 - FDA
Approves Expanded Use of Vonvendi for von Willebrand Disease, Including
for Certain Uses for Children |
| September 5, 2025 - FDA
Launches Green List to Protect Americans from Illegal Imported GLP-1
Drug Ingredients |
| September 4, 2025 - FDA
Announces Real-Time Release of Complete Response Letters, Posts Previously
Unpublished Batch of 89 |
| September 3, 2025 - FDA
Advances Rare Disease Drug Development with New Evidence Principles |
| September 2, 2025 - FDA
Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging
Following Increasing Reports of Accidental Exposure |
| August 22, 2025 - FDA
Begins Real-Time Reporting of Adverse Event Data |
| August 19, 2025 - HHS
Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm,
Protect U.S. Food Supply |
| August 14, 2025 - FDA
Approves First Immunotherapy for Recurrent Respiratory Papillomatosis |
| August 13, 2025 - Statement
from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction
of 7-OH Opioid Products |
| August 8, 2025 - FDA
Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization
of Orange Juice Regulations to Benefit American Growers |
| August 8, 2025 - A
Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing
Resolution of the IV Saline Solutions Shortage |
| August 7, 2025 - FDA
Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing |
| August 4, 2025 - FDA
Names Top HHS Lawyer as Chief Counsel |
| July 31, 2025 - FDA
Requires Major Changes to Opioid Pain Medication Labeling to Emphasize
Risks |
| July 29, 2025 - FDA
Takes Steps to Restrict 7-OH Opioid Products Threatening American
Consumers |
| July 28, 2025 - FDA
Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients |
| July 25, 2025 - FDA
Investigating Death of 8-Year-Old Boy Who Received Elevidys |
| July 23, 2025 - HHS,
FDA and USDA Address the Health Risks of Ultra-Processed Foods |
| July 22, 2025 - HHS,
FDA Praise Consumer Brands Association’s Vow to Remove Artificial
Colors from America’s Food Supply |
| July 21, 2025 - Stanford
faculty member George Tidmarsh, M.D., Ph.D. named Director of Center
for Drug Evaluation and Research |
| July 18, 2025 - FDA
Requests Sarepta Therapeutics Suspend Distribution of Elevidys and
Places Clinical Trials on Hold for Multiple Gene Therapy Products
Following 3 Deaths |
| July 16, 2025 - FDA
to Revoke 52 Obsolete Standards of Identity for Food Products |
| July 15, 2025 - FDA
Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine |
| July 14, 2025 - FDA
Approves Gardenia (Genipin) Blue Color Additive While Encouraging
Faster Phase-Out of FD&C Red No. 3 |
| July 10, 2025 - A
Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days
of Embracing Gold-Standard Science, Transparency and Common Sense |
| July 10, 2025 - FDA
Embraces Radical Transparency by Publishing Complete Response Letters |
| July 9, 2025 - FDA
Encourages Industry Leaders to Streamline, Enhance Product Recall
Communications to Safeguard Foods for Infants and Children |
| May 22, 2025 - FDA
Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party
Testing Firms |
| May 22, 2025 - FDA
and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During
Joint Operation |
| May 21, 2025 - FDA
takes steps to enhance state importation programs to help lower prescription
drug prices |
| May 16, 2025 - FDA
Clears First Blood Test Used in Diagnosing Alzheimer’s Disease |
| May 16, 2025 - FDA
to Host Inaugural, Independent, Scientific Expert Panel Open to Public |
| May 15, 2025 - FDA
Advances Robust, Transparent Post-Market Chemical Review Program to
Keep Food Supply Safe and Healthy |
| May 13, 2025 - FDA
Begins Action To Remove Ingestible Fluoride Prescription Drug Products
for Children from the Market |
| May 13, 2025 - HHS,
FDA Initiate Comprehensive Review of Nutrients in Infant Formula |
| May 13, 2025 - HHS,
FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers |
| May 9, 2025 - FDA
and NIH Announce Innovative Joint Nutrition Regulatory Science Program |
| May 9, 2025 - FDA
Approves Three Food Colors from Natural Sources |
| May 8, 2025 - FDA
Announces Completion of First AI-Assisted Scientific Review Pilot
and Aggressive Agency-Wide AI Rollout Timeline |
| May 6, 2025 - FDA
Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing
Facilities |
| April 22, 2025 - HHS,
FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food
Supply |
| April 17, 2025 - FDA
Commissioner Makary Announces New Policy on Individuals Serving on
FDA Advisory Committees |
| April 11, 2025 - FDA
Honored to Welcome HHS Secretary Robert F. Kennedy, Jr. to FDA Campus |
| April 10, 2025 - FDA
Announces Plan to Phase Out Animal Testing Requirement for Monoclonal
Antibodies and Other Drugs |
| April 1, 2025 - Martin
A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner |
| March 28, 2025 - FDA
Approves Novel Treatment for Hemophilia A or B, with or without Factor
Inhibitors |
| March 28, 2025 - FDA
Roundup: March 28, 2025 |
| March 28, 2025 - FDA
Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea
and Trichomoniasis |
| March 21, 2025 - FDA
Roundup: March 21, 2025 |
| March 20, 2025 - HHS,
FDA Announce Chemical Contaminants Transparency Tool for Foods |
| March 18, 2025 - HHS,
FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable,
and Nutritious Infant Formula for American Families |
| March 18, 2025 - FDA
Roundup: March 18, 2025 |
| March 14, 2025 - FDA
Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette
Use in One Year |
| March 14, 2025 - FDA
Roundup: March 14, 2025 |
| March 11, 2025 - FDA
Roundup: March 11, 2025 |
| March 7, 2025 - FDA
Roundup: March 7, 2025 |
| March 4, 2025 - FDA
Roundup: March 4, 2025 |
| January 30, 2025 - FDA
Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain |
| January 17, 2025 - FDA
Roundup: January 17, 2025 |
| January 16, 2025 - FDA
Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive
Scientific Review |
| January 15, 2025 - FDA
Proposes Significant Step Toward Reducing Nicotine to Minimally or
Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco
Products |
| January 14, 2025 - FDA
Proposes Requiring At-a-Glance Nutrition Information on the Front
of Packaged Foods |
| January 14, 2025 - FDA
Roundup: January 14, 2025 |
| January 10, 2025 - FDA
Roundup: January 10, 2025 |
| January 7, 2025 - FDA
Roundup: January 7, 2025 |
| January 6, 2025 - FDA
Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials |
| January 6, 2025 - FDA
Proposes Framework to Advance Credibility of AI Models Used for Drug
and Biological Product Submissions |
| January 6, 2025 - FDA
Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled
Medical Devices |
| January 6, 2025 - FDA
Proposes Updated Recommendations to Help Improve Performance of Pulse
Oximeters Across Skin Tones |
| January 3, 2025 - FDA
Roundup: January 3, 2025 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| January 17, 2025
Revised Emergency Use Authorization
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.)
At-Home OTC COVID-19 Diagnostic Tests
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.) -
Extended Expiration Date
CDRH
2024 Annual Report
MedSun
Newsletter - January 2025
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January 16, 2025
CDRH
Statement: Medical Device Supply Chain Vulnerabilities and the Public
Health Impact They Have on Our Most Vulnerable Patients
Update:
Evaluation of Airborne Chemicals from Neonatal Incubators - Letter
to Health Care Providers
Early
Alert: Infusion Pump Software Issue from Fresenius Kabi USA
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January 15, 2025
Definitions
and General Oversight: Laboratory Developed Tests FAQs (Updated)
Phaseout
Policy and Enforcement Discretion Policies: Laboratory Developed
Tests FAQs (Updated)
Medical
Device Reporting, Complaints, and Corrections & Removals Reporting:
Laboratory Developed Tests FAQs (Updated)
Class
I Recall: Endoscopic Vessel Harvesting (EVH) System Correction:
Getinge and Maquet Cardiovascular Update Use Instructions for VasoView
HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent
or Detached Heater Wires and Silicone Peeling or Detaching During
Use
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
- ASCA
2024 Annual Report
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January 14, 2025
Recognized
Consensus Standards Database (Updated)
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January 13, 2025
Revoked
Emergency Use Authorizations
- Access SARS-CoV-2 IgG (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
De Novo Decision Summary:
- DEN230027
- NaviCam ProScan
Premarket
Approval Application and Humanitarian Device Exemption Modular Review
- Guidance for Industry and FDA Staff
Class
I Recall: Outpatient Telemetry Correction: Philips Issues Correction
for Monitoring Service Application used with Mobile Cardiac Outpatient
Telemetry Due to Potential for Missed Information or Notifications
That May Impact Patient Care
Recalls,
Corrections and Removals (Devices) (Updated)
|
| January 8, 2025
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA - Molecular
Diagnostic Tests (Updated)
- DASH SARS-CoV-2 & Flu A/B Test (Nuclein, LLC)
Getting
a Radiation Emitting Product to Market: Frequently Asked Questions
(Updated)
Webinar:
Investigational Use Requirements for In Vitro Diagnostic Products
(IVDs), including Laboratory Developed Tests (LDTs) Under 21 CFR
812 - February 25, 2025
Laboratory
Developed Tests (Updated)
Consumer Information: PyloPlus
UBT System - P170022/S003
(ARJ Medical Inc.)
Federal
Register: Requests for Nominations: Technical Electronic Product
Radiation Safety Standards Committee
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January 7, 2025
Consumer Information: Oncomine
Dx Target Test - P160045/S046
(Life Technologies Corporation)
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January 6, 2025
Pulse
Oximeters for Medical Purposes - Non-Clinical and Clinical Performance
Testing, Labeling, and Premarket Submission Recommendations - Draft
Guidance for Industry and Food and Drug Administration Staff
Pulse
Oximeters (Updated)
Validation
of Certain In Vitro Diagnostic Devices for Emerging Pathogens During
a Section 564 Declared Emergency - Draft Guidance for Industry and
Food and Drug Administration Staff
Artificial
Intelligence-Enabled Device Software Functions: Lifecycle Management
and Marketing Submission Recommendations - Draft Guidance for Industry
and Food and Drug Administration Staff
Evaluation
of Sex-Specific and Gender-Specific Data in Medical Device Clinical
Studies - Draft Guidance for Industry and Food and Drug Administration
Staff
Notifying
FDA of a Permanent Discontinuance or Interruption in Manufacturing
of a Device Under Section 506J of the FD&C Act - Guidance for
Industry and Food and Drug Administration Staff
Medical
Device Supply Chain and Shortages (Updated)
Supply
and Shortages of Medical Devices: Frequently Asked Questions (Updated)
506J
Device List (Updated)
Webinar
- Final Guidance: Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing of a Device Under Section 506J of
the FD&C Act - March 4, 2025
Federal
Register: Artificial Intelligence-Enabled Device Software Functions:
Lifecycle Management and Marketing Submission Recommendations; Draft
Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Validation of Certain In Vitro Diagnostic Devices for
Emerging Pathogens During a Section 564 Declared Emergency; Draft
Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Pulse Oximeters for Medical Purposes - Non-Clinical and
Clinical Performance Testing, Labeling, and Premarket Submission
Recommendations; Draft Guidance for Industry and Food and Drug Administration
Staff
Federal
Register: Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance
for Industry and Food and Drug Administration Staff
Federal
Register: Evaluation of Sex-Specific and Gender-Specific Data in
Medical Device Clinical Studies; Draft Guidance for Industry and
Food and Drug Administration Staff
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| January 3, 2025
Federal
Register: Requests for Nominations: National Mammography Quality
Assurance Advisory Committee
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| January 2, 2025
Total
Product Life Cycle Advisory Program (TAP) (Updated)
MQSA
National Statistics (Updated)
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See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
- January
2025
- February 2025
- March 2025
- April 2025
- May 2025
- June 2025
- July 2025
- August 2025
- September 2025
- October 2025
- November 2025
- December 2025
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