FDA Webview
X
latest-news

Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and focus on doing things right for patients.

latest-news

A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to address a progressive disease.

LATEST NEWS

View All
motusgi
Will the Next Commissioner Learn from Makary’s Mistakes?

Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and focus on doing things right for patients.

motusgi
FDA Has to Build CRISPR Edit Review Protocol

A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to address a progressive disease.

motusgi
Naseem Jaffrani BIMO Violation

FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the investigational plan.

motusgi
Guidance on Drug Food Effects Studies

FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
Read More
FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

medical-devices
Read More
White House Reportedly Moves to Oust Commissioner Makary

Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

medical-devices
Read More
Atara says FDA outlined potential path for Cell Therapy Resubmission

Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...

Biologics

View All
medical-devices
Read More
FDA Has to Build CRISPR Edit Review Protocol

A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISPR gene edit to addre...

medical-devices
Read More
ImmunityBio’s Anktiva sBLA for Expanded Use Accepted by FDA

FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with...

medical-devices
Read More
FDA Covid-19 Pediatric Review Raises New Scrutiny

FDA faces renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the release of documents by ...

medical-devices
Read More
Democratic Health Leaders Question FDA Study Suppression

Democratic leaders on the House Energy and Commerce Committee accuse HHS secretary Robert F. Kennedy Jr. of suppressing scientific research supporting...

FDA General

View All
medical-devices
Read More
Will the Next Commissioner Learn from Makary’s Mistakes?

Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to reset its operation and...

medical-devices
Read More
Health Affairs Commentary Says Makary Left FDA ‘Weaker’

Two prominent drug-policy scholars sharply criticize former FDA commissioner Marty Makary in a Health Affairs commentary, arguing that his tenure weak...

medical-devices
Read More
More FDA Turmoil: Drug, Biologics Leaders Removed

FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.

medical-devices
Read More
FDA May be OK Under Loper Bright: Article

University of Missouri law professor Erika Lietzan says FDA may not suffer as much under the Supreme Court’s Loper Bright decision as policy analysts ...

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

motusgi
Read More
Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

motusgi
Read More
PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

motusgi
Read More
Purdue Sentencing Sets $5.3 Billion in Criminal Penalties

A federal court sentences Purdue Pharma to pay more than $5 billion in criminal penalties for its ro...

Human Drugs

View All
motusgi
Read More
Naseem Jaffrani BIMO Violation

FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical ...

motusgi
Read More
Guidance on Drug Food Effects Studies

FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies fo...

motusgi
Read More
Bipartisan Bill to Lower Rx Drug Costs

Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-call...

motusgi
Read More
All India Institute Clinical Trial Issues

FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All I...

Marketing

View All
motusgi
Read More
DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

motusgi
Read More
Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

motusgi
Read More
Advertising Experts Critique FDA’s Increasing Enforcement

Pharmaceutical advertising experts react to FDA’s dramatically altered enforcement approach toward p...

motusgi
Read More
Nubeqa TV Ad, Video Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Bayer that a video and TV ad for its Nubeqa ...

Medical Devices

View All
motusgi
Read More
FDA Approves Guardant Health’s Next-Generation Guardant360 Liquid CDx

FDA approves Guardant Health’s next-generation Guardant360 Liquid CDx, a blood-based comprehensive g...

motusgi
Read More
Implantica Submits Final FDA Response for RefluxStop PMA

Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agency’s rem...

motusgi
Read More
Valar Labs Wins Breakthrough Status for AI Bladder Cancer Test

FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.

motusgi
Read More
TEMPO Digital Health Pilot FAQs

FDA publishes frequently asked questions covering eligibility, statement of interest, and selection ...