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Medical ethicist Arthur Caplan voices concerns about human subject protection in clinical trials due to significant staff cuts at FDA and HHS.

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A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharma’s compounded 100 mg indomethacin suppository.

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FDA, HHS Cuts Can Hurt Trial Oversight: Caplan

Medical ethicist Arthur Caplan voices concerns about human subject protection in clinical trials due to significant staff cuts at FDA and HHS.

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Order Wells Pharma Indomethacin Off Market: Petition

A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharma’s compounded 100 mg indomethacin suppository.

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FDA Approves First Interchangeable Perjeta Biosimilar

FDA approves Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentech’s Perjeta (pertuzumab), a HER2-targeted therapy for breast cancer.

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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 over social media influencer promotions for FDA-regulated products.

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Animal Drugs

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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 Approves First Interchangeable Perjeta Biosimilar

FDA approves Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentech’s Perjeta (pertuzumab), a HER2-t...

medical-devices
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Outlook Therapeutics BLA Resubmitted for Wet AMD

FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...

medical-devices
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Petition Urges FDA to Ease Oversight of Stem Cell Products

A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therapies.

medical-devices
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enGene Reports 62% Response Rate for Gene Therapy

enGene says Phase 2 data showed that its gene therapy detalimogene voraplasmid produced a 62% complete response rate at six months in patients with hi...

FDA General

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medical-devices
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‘MAHA Summit’ to Hear from Vance, Kennedy, Makary

A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Makary, among many oth...

medical-devices
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FDA Unveils ‘Plausible Mechanism’ Approval Pathway

FDA introduces a new regulatory framework — the “plausible mechanism pathway” — designed to speed approval of highly personalized therapies for rare g...

medical-devices
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Trust Needed to Boost FDA Morale: Grossman

FDA Matters president Steven Grossman says FDA’s top officials can improve agency morale by increasing the trust felt by lower-level staff that they a...

medical-devices
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Makary Reassures Stakeholders that FDA Remains Robust

Addressing a Milken Institute annual summit, FDA commissioner Marty Makary reassures stakeholders that despite recent departures among its senior rank...

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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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Order Wells Pharma Indomethacin Off Market: Petition

A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharma’...

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FDA Qualifies GLDH Biomarker

FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical tr...

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Gilead’s Single-Tablet HIV Regimen Meets Trial Endpoint

Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacap...

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OGD Four-Part Harmony MAPP

The CDER Office of Generic Drugs publishes a MAPP to help assessors use the four-part harmony approa...

Marketing

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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,...

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40 DTC Untitled Letters Posted by FDA

FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issu...

Medical Devices

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What FDA Might Want in Chatbot Therapy for Depression

Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the ag...

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FDA OKs Companion Diagnostic for Endometrial Cancer Therapy

FDA approves Promega’s OncoMate MSI Dx Analysis System as a companion diagnostic for identifying end...

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Complying with QMSR ‘Critical Business Strategy’: Attorneys

Alston & Bird attorneys urge medical device companies to move quickly to prepare to implement FDA’s ...

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FDA OKs Aqua Medical IDE for Endoscopic Technology Trial

FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Pr...