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Media reports suggest FDA commissioner Marty Makary’s time at FDA may be limited due to White House tension over his management of the agency.

latest-news

Pharmaceutical advertising experts react to FDA’s dramatically altered enforcement approach toward prescription drug promotion since last fall.

LATEST NEWS

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Report says Makary May Face Ouster Amid White House Tensions

Media reports suggest FDA commissioner Marty Makary’s time at FDA may be limited due to White House tension over his management of the agency.

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Advertising Experts Critique FDA’s Increasing Enforcement

Pharmaceutical advertising experts react to FDA’s dramatically altered enforcement approach toward prescription drug promotion since last fall.

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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 annual conference in Washington, DC 5/6, emphasizing regulatory flexibility, scientific rigor and increased engagement with industry.

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Sanofi Seeks Removal of Tzield From FDA Priority Review Program

Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agency’s National Priority Voucher review program following an internal disagreement over the drug’s supplemental application.

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Animal Drugs

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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, ...

medical-devices
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2 CDER Postmarketing MAPPS Out

CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.

medical-devices
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Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

medical-devices
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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

Biologics

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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 ...

medical-devices
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Celgene Cell Therapy Facility Hit with Form 483

FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile p...

FDA General

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medical-devices
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Report says Makary May Face Ouster Amid White House Tensions

Media reports suggest FDA commissioner Marty Makary’s time at FDA may be limited due to White House tension over his management of the agency.

medical-devices
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One-Day Inspection Pilot Underway at FDA

FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection...

medical-devices
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Turmoil, Turnover and Industry Backlash Mark Makary’s Tenure

New Bloomberg reporting that FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makary’s tenure.

medical-devices
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House Committee Advances FDA Funding Bill Amid Policy Disputes

The U.S. House Appropriations Committee votes to approve a spending bill to fund FDA for fiscal year 2027.

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Federal Register

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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...

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Insulet Class 1 Recall of Insulin Pump Components

Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result i...

Human Drugs

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Sanofi Seeks Removal of Tzield From FDA Priority Review Program

Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agency’s National Priority Vou...

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New CDER Biologics Compliance Program Explained

Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre...

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Brookings Economist Backs FDA Biosimilar Draft Guide

A Brookings Institution health economist voices support for FDA’s revisions to a guidance on questio...

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House Committee Would Limit Foreign Trial Data

Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from acc...

Marketing

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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...

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Alymsys Patient Brochure False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosi...

Medical Devices

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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 ...

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Ban Mercury Amalgam Fillings: Petition

Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercu...