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Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pressure that she experienced to fire senior career officials and replace them with compliant appointees.

latest-news

FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of advisory committees in reviewing and making recommendations on drug applications.

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Ex-CDC Chief Says FDA Facing Similar Political Pressure

Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pressure that she experienced to fire senior career officials and replace them with compliant appointees.

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Are FDA Advisory Committees Doomed?

FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to limit or eliminate the role of advisory committees in reviewing and making recommendations on drug applications.

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Exactech Pays $8 Million in Whistleblower Cases

The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whistleblowers’ allegations that the company violated the False Claims Act by knowingly marketing components in total knee replacement systems that failed prematurely.

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Lilly’s Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial

Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight loss results than Novo Nordisk’s oral semaglutide in a late-stage head-to-head study.

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Animal Drugs

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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.

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...

Biologics

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medical-devices
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Krystal Wins Expanded Label for Gene Therapy

FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), adding patients with d...

medical-devices
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CBER Says AstraZeneca FluMist Ad Misled Viewers

CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement for its nasal spray ...

medical-devices
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CBER to Host Gene Therapy Manufacturing Town Hall

CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.

medical-devices
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Prasad Reassumes Chief Medical/Scientific Officer Role

FDA commissioner Marty Makary reinstates CBER director Vinay Prasad’s previous additional duties as the agency’s chief medical and scientific officer.

FDA General

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medical-devices
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FDA Pushes Plan to Scale Back Advisory Committees

FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice of convening indepe...

medical-devices
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FDA Orders Crackdown on Misleading Prescription Drug Ads

In a new crackdown on drug advertising, FDA orders pharmaceutical companies to remove any “noncompliant ads” and bring all promotional communications ...

medical-devices
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FDA Digital Health Leader Leaves for Mayo Clinic

Former FDA Digital Health Center of Excellence acting director Sonja Fulmer leaves the agency to accept a position at Mayo Clinic as senior director o...

medical-devices
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Gottlieb Warns HHS Could Undermine Pediatric Vaccines

Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report on autism to challen...

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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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Ex-CDC Chief Says FDA Facing Similar Political Pressure

Former CDC director Susan Monarez says FDA and other health agencies are facing similar political pr...

motusgi
Read More
Are FDA Advisory Committees Doomed?

FDA Matters founder Steven Grossman speculates on why FDA commissioner Martin Makary may want to lim...

motusgi
Read More
Lilly’s Oral Diabetes Drug Outperforms Rival in Head-to-Head Trial

Eli Lilly reports that it oral diabetes drug orforglipron achieved stronger blood sugar and weight l...

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Read More
J&J Reports Positive Data in Psoriasis Drug

Johnson & Johnson reports favorable data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies that showed...

Marketing

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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 ...

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Bill to Require Drug Price in DTC Ads

Five House members introduce a bill to require DTC television ads to include the drug’s list price.

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Sen. Durbin Calls for Crackdown on DTC Telehealth

Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies’ growing use of direct-...

Medical Devices

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Exactech Pays $8 Million in Whistleblower Cases

The Justice Department says Gainesville, FL-based Exactech is paying $8 million to resolve four whis...

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Becton Dickinson Expands Alaris Pump Recall

Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 addit...

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Multiple Violations in Illegal Marketing of SeniorLife.AI

FDA warns Bellevue, WA-based SeniorLife.AI about multiple violations in its illegal marketing of an ...

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Alert on Medline Kits with Medtronic Heart Catheter

FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtro...