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A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to increase surrogate endpoint transparency by providing information on the endpoints’ strength of evidence of clinical benefit.

latest-news

A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to restrict access to the abortion medication mifepristone.

LATEST NEWS

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FDA Prodded to Improve Surrogate Endpoint Transparency

A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to increase surrogate endpoint transparency by providing information on the endpoints’ strength of evidence of clinical benefit.

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Biotech Leaders Support Access to Mifepristone

A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to restrict access to the abortion medication mifepristone.

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Support for Biosimilar Legislation

Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the distinction between biosimilars and interchangeable biosimilars.

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FDA Urged to Expand Real-World Data Use

A bioethicist’s opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of approved medical products.

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Animal Drugs

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medical-devices
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Sumitomo Pharma Gets Fast Track Status for Nuvisertib

FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.

medical-devices
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Researchers Challenge FDA Lamictal Safety Warning

Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults with epilepsy and conco...

medical-devices
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GSK Plans for Antibiotic NDA in 2nd Half

GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...

medical-devices
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Prothena Scraps Birtamimab After Phase 3 Miss

Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...

Biologics

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medical-devices
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Vaccine Regulation Now ‘a Political Process’: Gottlieb

Former FDA commissioner Scott Gottlieb raises significant questions about the current administration’s handling of vaccines and vaccine innovation in ...

medical-devices
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Positive Phase 3 Results for Moderna Flu Vaccine

Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.

medical-devices
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InVia Fertility Specialists HCT/Ps Violations

FDA warns Hoffman Estates, IL-based InVia Fertility Specialists about multiple violations of regulations governing human cells, tissues, and cellular ...

medical-devices
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Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit

A group of medical societies files suit against HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary to reverse a 5/27 decision to re...

FDA General

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medical-devices
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FDA Urged to Expand Real-World Data Use

A bioethicist’s opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of...

medical-devices
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FDA Elsa Rollout a ‘Nuanced Dance’: Consultant

Consultant Erika Roberts says FDA’s rollout of its staff AI tool Elsa is a good first step, but much more needs to be done to reach the potential of u...

medical-devices
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FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 7.

medical-devices
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Reverse FDA Restructuring: Former GOP Representative

Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated companies, patients...

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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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FDA Prodded to Improve Surrogate Endpoint Transparency

A Federation of American Scientists online paper says FDA, other federal research agencies, and Cong...

motusgi
Read More
Biotech Leaders Support Access to Mifepristone

A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty...

motusgi
Read More
Support for Biosimilar Legislation

Forty health advocacy groups led by the Association for Accessible Medicines voice their support for...

motusgi
Read More
CGMP Violations at Exela Pharma Sciences

FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufac...

Marketing

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DTC Ads Kennedy’s Next Target?

Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope...

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Senators Introduce Bill to Ban DTC Drug Advertising

Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-...

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Attorney Warns: FDA Watching Professional Promotion

Attorney Nathan Downing says medical product companies should review their professional promotions a...

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RFK Jr. Attacks ‘Corrupt’ Drug Firms and DTC Ads

In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault agains...

Medical Devices

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Multiple Insightra Medical Violations Cited

FDA warns Clarksville, TN-based Insightra Medical about multiple violations in its production of int...

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Expanded Parkinson’s Use OK’d for Insightec Device

FDA approves an expanded indication for Insightec’s Exablate Neuro platform for staged bilateral pal...

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Abiomed Pump Controller Needs Update: FDA

FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in thr...

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FDA Clears Philips’ SmartSpeed Precise Software

FDA clears Philips’ SmartSpeed Precise AI-enhanced software for MRI systems.