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Former FDA commissioner Scott Gottlieb predicts just-confirmed FDA commissioner Marty Makary will soon face political interference from the Trump administration attempting to impact decision-making at the agency.

latest-news

Realizing that essential FDA staff have been fired, the agency asks some employees to return for 60 days to assist in the transition to a new staffing model.

LATEST NEWS

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Makary Will Face Political Interference Soon: Gottlieb

Former FDA commissioner Scott Gottlieb predicts just-confirmed FDA commissioner Marty Makary will soon face political interference from the Trump administration attempting to impact decision-making at the agency.

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Some FDA Workers May Get Temporary Duty: Report

Realizing that essential FDA staff have been fired, the agency asks some employees to return for 60 days to assist in the transition to a new staffing model.

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Reorganization Will Block Information Flow

FDA Webview Contributing Editor John Hope says the dismissal of agency communications staff will hurt information flow to the public.

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Accelerated Approval Faces Scrutiny After Cancer Drug Review

FDA’s accelerated approval program faces renewed scrutiny after a recent JAMA study highlighted concerns about cancer drugs that remain available despite failing to show clinical benefit in post-markeeting trials.

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Animal Drugs

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medical-devices
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Industry Sounds the Alarm on FDA Staff Cuts

Industry associations sound alarms and frustrations as they weigh how FDA staff cuts will impact product development, FDA reviews and approvals.

medical-devices
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AstraZeneca Touts New Tagrisso Data

AstraZeneca says new study data on Tagrisso (osimertinib) show an “improved overall survival trend” in certain patients with non-small cell lung cance...

medical-devices
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Alnylam Gets Additional Approval for Amvuttra

FDA approves an Alnylam Pharmaceuticals supplemental NDA for Amvuttra (vutrisiran), an RNAi therapeutic for treating transthyretin amyloidosis with ca...

medical-devices
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Pancreatic Cancer Drug Gets Orphan Status

FDA awards PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer.

Biologics

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medical-devices
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FDA Misses Novavax Covid Vaccine Review Action

FDA misses its 4/1 user fee review action target date on a Novavax BLA seeking full approval for its current Covid-19 vaccine.

medical-devices
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Marks’ Firing Challenges RFK Jr.’s Fitness for Office

FDA Webview editor Jim Dickinson analyzes the firing of CBER director Peter Marks and finds it a challenge to HHS secretary and vaccine skeptic Robert...

medical-devices
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Smallpox/Mpox Vaccine OK’d Despite CBER Turmoil

FDA approves Bavarian Nordic’s freeze-dried formulation of Jynneos smallpox and mpox vaccine despite concerns over CBER director Peter Marks’ departur...

medical-devices
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Advocates Blast Hiring ‘Quack’ for Autism Study

The Autism Self-Advocacy Network sharply criticizes HHS for hiring “quack” David Geier to study a potential link between autism and vaccines, which th...

FDA General

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medical-devices
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Makary Will Face Political Interference Soon: Gottlieb

Former FDA commissioner Scott Gottlieb predicts just-confirmed FDA commissioner Marty Makary will soon face political interference from the Trump admi...

medical-devices
Read More
Some FDA Workers May Get Temporary Duty: Report

Realizing that essential FDA staff have been fired, the agency asks some employees to return for 60 days to assist in the transition to a new staffing...

medical-devices
Read More
Reorganization Will Block Information Flow

FDA Webview Contributing Editor John Hope says the dismissal of agency communications staff will hurt information flow to the public.

medical-devices
Read More
Can FDA “Do More With Less?”: McClellan

Former FDA commissioner Mark McClellan says it will be a challenge for the agency to come through the massive reorganization and staff reduction that ...

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Federal Register

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FDA Revokes EUAs on 3 Beckman Coulter Tests

Federal Register notice: FDA revokes Emergency Use Authorizations issued to Beckman Coulter for thre...

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Device Consensus Standards Publication

Federal Register notice: FDA updates its publication on modifications to the list of recognized cons...

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FDA Withdraws Sage’s NDA for Zulresso

Federal Register notice: FDA withdraws the approval of a Sage Therapeutics NDA for Zulresso (brexano...

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Garmendia Permanently Debarred Over Trial Fraud

Federal Register notice: FDA rejects a request for a hearing submitted by Bernardo Garmendia, and is...

Human Drugs

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Accelerated Approval Faces Scrutiny After Cancer Drug Review

FDA’s accelerated approval program faces renewed scrutiny after a recent JAMA study highlighted conc...

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CRL for Aldeyra’s Reproxalap for Dry Eye

FDA issues a complete response letter to Aldeyra’s NDA for reproxalap to treat dry eye disease, citi...

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BeiGene Drops Ociperlimab Development in Lung Cancer

BeiGene scraps the development of BGB-A1217 (ociperlimab), an anti-TIGIT antibody, as a potential tr...

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Sanofi’s Rilzabrutinib Gets Orphan Drug Designation

FDA grants orphan drug designation to Sanofi’s investigational drug rilzabrutinib for two rare disea...

Marketing

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Lytgobi Web Page False, Misleading: FDA

The CDER Office of Prescription Drug Promotion cautions Taiho Oncology about misleading efficacy pre...

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Plus Therapeutics Gets Orphan Statis for Radiotherapy

FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiothera...

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Capricor BLA for Duchenne-related Cardiomyopathy

FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treat...

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OPDP Hits Edenbridge Pharma Over Promos

CDER's Office of Prescription Drug Promotion sends an untitled letter to Edenbridge Pharmaceuticals ...

Medical Devices

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Medivis Spinal Navigation Device Cleared

FDA clears a Medivis 510(k) for its Spine Navigation platform that uses augmented reality and artifi...

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FDA Says Rex Implants Illegally Marketing Devices

FDA warns Columbus, OH-based Rex Implants that it is illegally manufacturing and distributing three ...

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Bausch + Lomb Recalls enVista Intraocular Lenses

Bausch + Lomb recalls all enVista intraocular lenses due to increasing adverse event reports of toxi...

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Multiple Violations in Next Science Inspection

FDA warns Jacksonville, FL-based Next Science that it is illegally manufacturing and distributing ad...