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FDA releases the form FDA-483 with six observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany.

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FDA publishes 76 new and revised product-specific guidances intended to speed generic drug development and approval.

LATEST NEWS

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Baxter Oncology FDA-483 Out

FDA releases the form FDA-483 with six observations from an inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany.

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76 New or Revised Product-Specific Guidances Out

FDA publishes 76 new and revised product-specific guidances intended to speed generic drug development and approval.

motusgi
White House Inks Deals with Lilly and Novo Nordisk

The Trump Administration announces new agreements with Eli Lilly and Novo Nordisk to lower U.S. prices for several products, including the GLP-1 medications Ozempic and Wegovy.

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6 Additional National Priority Vouchers Awarded

FDA announces six additional drugs awarded Commissioner’s National Priority vouchers.

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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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Inspection of Alvotech’s Biosimilar Ends in Rejection

FDA sends Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals’ Simponi (golimumab), due to deficiencies ...

medical-devices
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FDA Shifts Stance on AMT-130 BLA Data

FDA tells gene therapy company uniQure that the agency may no longer view the company’s Phase 1-2 data for its Huntington’s disease therapy AMT-130 as...

medical-devices
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Interchangeability Status on Celltrion Biosimilars

FDA grants interchangeability designations to Celltrion’s denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), making them ...

medical-devices
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J&J Seeks Stelara Expanded Use

Johnson & Johnson files a supplemental BLA seeking to expand the use of its biologic therapy Stelara (ustekinumab) to treat children aged two years an...

FDA General

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medical-devices
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White House Supporting Makary in Turmoil: Report

Politico reports that President Trump and HHS are standing by FDA commissioner Marty Makary as the agency weathers the sudden departure of CDER direct...

medical-devices
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Sen. Banks Presses FDA to Ramp Up Foreign Inspections

Sen. Jim Banks (R-IN) urges FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging...

medical-devices
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GOP Senators Call on FDA to Restrict Generic Mifepristone

Fifty-one Republican senators urge FDA to restrict access to abortion pills following the agency’s recent approval of a new generic version of mifepri...

medical-devices
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Public Rating of FDA, Others Dropping

A Gallup Poll shows that Americans’ ratings of FDA and many other federal agencies have dropped in the last year to at or near their lowest point.

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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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Baxter Oncology FDA-483 Out

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

motusgi
Read More
76 New or Revised Product-Specific Guidances Out

FDA publishes 76 new and revised product-specific guidances intended to speed generic drug developme...

motusgi
Read More
White House Inks Deals with Lilly and Novo Nordisk

The Trump Administration announces new agreements with Eli Lilly and Novo Nordisk to lower U.S. pric...

motusgi
Read More
6 Additional National Priority Vouchers Awarded

FDA announces six additional drugs awarded Commissioner’s National Priority vouchers.

Marketing

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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...

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Makary JAMA Piece Explains DTC Ad Crackdown

FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to ...

Medical Devices

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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...

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Safety Data Update on Hintermann Ankle Device

FDA issues an updated safety communication confirming long-term post-approval data showing that the ...

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FDA Clears Tosoh’s Next-Generation HbA1c Analyzer

FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for ...

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2 QSR Violations at Qinjiang Kingphar Medical

FDA warns China’s Qinjiang Kingphar Medical Material Co. about Quality System violations in its prod...