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FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.

latest-news

FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.

LATEST NEWS

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Two Digital Health Guidances Published

FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.

motusgi
Formal Dispute Resolution Guidance

FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.

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End-of-December Warning Letters

FDA releases substantive Warning Letters in the last two weeks of December 2025.

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FDA Releases Sun Pharmaceutical FDA-483

FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufacturing facility in Halol, Gujarat, India.

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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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Industry Recommendations for BsUFA 4 Reauthorization

A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in the BsUFA reauthoriza...

medical-devices
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FDA to Review Inovio BLA to Treat RRP

FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.

medical-devices
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Hoeg, Prasad Draw Vaccine Concerns

Two lengthy news service stories raise questions about FDA’s approach to vaccines being espoused by CDER director Tracy Beth Høeg and CBER director Vi...

medical-devices
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FDA Cites GSK Hungary Vaccine Plant

FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, includ...

FDA General

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medical-devices
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End-of-December Warning Letters

FDA releases substantive Warning Letters in the last two weeks of December 2025.

medical-devices
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FDA Tumult Keeps Makary Under Microscope: NYT Article

The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, raising concerns among ...

medical-devices
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Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congres...

medical-devices
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FDA Commissioner Defends Vaccine Stance, Transparency Push

In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...

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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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Formal Dispute Resolution Guidance

FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrativ...

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FDA Releases Sun Pharmaceutical FDA-483

FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical M...

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Alumis Positive Data Reported for Psoriasis Drug

Alumis says envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in ...

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13 Potential New FAERS Drug Safety Signals

FDA releases a list of 13 potential safety signals identified in drugs between 7/2025 and 9/2025.

Marketing

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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...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

Medical Devices

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Two Digital Health Guidances Published

FDA publishes digital health guidances relating to low-risk general wellness products and clinical d...

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Dexcom Glucose Monitor Software Correction is Class 1

FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous gluco...

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FDA Town Hall on Quality Management System Regulation

FDA announces a 1/14 town hall to discuss its Quality Management System Regulation (QMSR) and its ef...

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FDA Sends Warning Letters to Makers of Breast Binders

FDA begins enforcement actions against companies illegally marketing breast binders to children, pla...