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Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the-counter acetaminophen-containing products.

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FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during production.

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Add Warning to OTC Acetaminophen Product Labels: Petition

Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the-counter acetaminophen-containing products.

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Sun Recalls 1 Batch of Doxorubicin HCl

FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during production.

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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 first feared.

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AEMS May Mean Increased Stakeholder Scrutiny: Column

Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being available in the agency’s new Adverse Event Monitoring System.

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Animal Drugs

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medical-devices
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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
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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
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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 ...

medical-devices
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Lilly to Seek FDA Approval for Foundayo in Diabetes

Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...

Biologics

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medical-devices
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Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy

FDA approves a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harb...

medical-devices
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CBER Acting Head Highlights Regulatory Flexibility, AI and Rare Disease Priorities

CBER acting director Katherine Szarama discusses an expansive vision for the biologics center during remarks at the Food and Drug Law Institute’s annu...

medical-devices
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Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...

medical-devices
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Town Hall on BLA Submissions for Cell and Gene Therapies

FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER ...

FDA General

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medical-devices
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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 ...

medical-devices
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Despite Makary Leaving, Industry Could Feel Pressure: Analysis

Analysts and investors interviewed by Reuters see a short-term positive reaction to the departure of Marty Makary, but caution that a prolonged leader...

medical-devices
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Inspection Pilot May be Permanent as FDA Expands AI-Driven Oversight

A King & Spalding legal analysis examines FDA’s newly announced pilot program for one-day inspectional assessments, suggesting it may signal a long-te...

medical-devices
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FDA Commissioner Makary Resigns After Administration Pressure

FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was preparing to remove hi...

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Federal Register

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FDA Delays Review Action on Alzheimer’s Drug

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

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Alnylam Pharma’s Web Promo is Misleading: FDA

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

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

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

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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

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Add Warning to OTC Acetaminophen Product Labels: Petition

Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instruc...

motusgi
Read More
Sun Recalls 1 Batch of Doxorubicin HCl

FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass partic...

motusgi
Read More
AEMS May Mean Increased Stakeholder Scrutiny: Column

Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny du...

motusgi
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FDA Publishes 2 Analgesic Draft Guidances

FDA publishes draft guidances on developing non-opioid analgesics for chronic pain and facilitating ...

Marketing

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Brukinsa TV Ad ‘False or Misleading’: OPDP

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

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Advertising Experts Critique FDA’s Increasing Enforcement

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

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Nubeqa TV Ad, Video Misleading: FDA

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

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Will the Push for DTC Pre-Review Grow?

Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congres...

Medical Devices

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Boston Scientific Device Correction on Certain Pacemakers

Boston Scientific begins a Class 1 recall (device correction) involving certain pacemakers and cardi...

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Guidance On Patient-Matched Guides for Orthopedic Implants

FDA posts a new guidance detailing how manufacturers should design and submit regulatory application...

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Unetixs Vascular Selling Illegal Devices: FDA

FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ...

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FDA’s Early QMSR Priorities Seen

A Quality Magazine article explains what FDA investigators have focused on in their initial Quality ...