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A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reductions and organizational restructuring that could further strain its oversight capacity.

latest-news

FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Alameda, CA.

LATEST NEWS

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FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO

A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reductions and organizational restructuring that could further strain its oversight capacity.

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Abbott Diabetes Care QS Violations

FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitoring systems at a facility in Alameda, CA.

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Former FDA LASIK Official Morris Waxler Dies at 88

Former CDRH branch chief Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the procedure, dies at the age of 88 due to a stroke.

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FDA Cautious Stance on CAR-T Cell Therapies for Autoimmune Diseases

An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen receptor T-cell therapies for autoimmune and rheumatic diseases.

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Animal Drugs

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medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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medical-devices
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FDA Cautious Stance on CAR-T Cell Therapies for Autoimmune Diseases

An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen receptor T-cell therap...

medical-devices
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Datroway sBLA for Triple-Negative Breast Cancer Under Review

FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibody–drug conjugate Datroway (datopotamab deruxtecan) as a potential first-l...

medical-devices
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Kennedy Ally Says Makary Blocking Covid Shot Withdrawal

Axios reports that the vice chair of the CDC Advisory Committee on Immunization Practices says the Pfizer and Moderna Covid mRNA vaccines should be re...

medical-devices
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Summit BLA for Lung Cancer Therapy

FDA accepts for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth f...

FDA General

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medical-devices
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FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO

A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reducti...

medical-devices
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FDA Official’s Personal Legal Actions Trigger Ethics Probe

HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled the federal governmen...

medical-devices
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Guide on Device Cybersecurity Released

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

medical-devices
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Symposium on Clinical Trials, Bioequivalence and Pharmacovigilance

U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for clinical trials, bioe...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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Repeat CGMP Violations at Kirkman Drug Manufacturing

FDA warns the Lake Oswego, OR-based Kirkman drug manufacturing facility about repeat CGMP violations...

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12 Observations in Baxter Oncology FDA-483

FDA releases the form FDA-483 with 12 observations from an inspection at the Baxter Oncology drug ma...

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FDA Issues Complete Response on Subcutaneous Saphnelo

FDA sends AstraZeneca a complete response letter rejecting approval of its BLA for a subcutaneous fo...

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Representative Questions Voucher Program Legality

Rep. Jake Auchincloss calls on FDA to affirm or refute his conclusion that the Commissioner’s Nation...

Marketing

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

Medical Devices

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Abbott Diabetes Care QS Violations

FDA warns Abbott Diabetes Care about Quality System violations in its production of glucose monitori...

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Former FDA LASIK Official Morris Waxler Dies at 88

Former CDRH branch chief Morris Waxler, who was involved in the original approval of laser eye surge...

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QS, MDR Violations at Mexico’s Unomedical Device

FDA warns Mexico’s Unomedical Device about Quality System and Medical Device Reporting violations in...

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Early Alert on Abiomed Impella RP Heart Pumps

FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain A...