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FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspection last year.

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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 virtual session will feature regulatory experts addressing common questions about BLA readiness and submission strategies.

LATEST NEWS

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Allergan’s Ireland Plant Hit With 483 After Inspection

FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspection last year.

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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 virtual session will feature regulatory experts addressing common questions about BLA readiness and submission strategies.

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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PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations could hinder innovation in precision medicine.

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Expanded Access Program for Promising Pancreatic Cancer Drug

FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receive the drug outside of clinical trials.

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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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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...

medical-devices
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FDA Still Weighing Potential CBER Director Candidates

FDA commissioner Marty Makary says the agency is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the a...

medical-devices
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Intellia Rolling BLA for Hereditary Angioedema CRISPR Therapy

Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treat...

FDA General

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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.

medical-devices
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FDA Evaluating Measures to Modernize Clinical Trials

FDA seeks to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a broader pilot program...

medical-devices
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Gene Therapy Approved for Inherited Hearing Loss

FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.

medical-devices
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Loper Bright Affecting Regulation of Synthetic Biology: Column

A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDA’s regulatory framework under the Supreme Court’s Loper Bright ...

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Federal Register

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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...

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Political Pressure on Psychedelics May Undermine FDA Approvals: Experts

Concerns that political pressure could undermine the U.S. drug approval system intensify this week a...

Human Drugs

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Allergan’s Ireland Plant Hit With 483 After Inspection

FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan...

motusgi
Read More
Expanded Access Program for Promising Pancreatic Cancer Drug

FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolut...

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Eugia Pharma Specialties FDA-483 Out

FDA releases the form FDA-483 with three observations from an inspection at India’s Eugia Pharma Spe...

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Keep GLP-1s Off Bulks List: FDA

FDA proposes not to include semaglutide, tirzepatide, and liraglutide on the 503 Bulks List of drugs...

Marketing

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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...

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Lucemyra Web Site Home Page False or Misleading: FDA

FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucem...

Medical Devices

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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...

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FDA, CMS Unveil ‘RAPID’ to Speed Device Coverage Decisions

FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for in...

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FDA Denies Petition to Withdraw Approval of VenaSeal

FDA denies a citizen petition seeking to withdraw approval of Covidien’s VenaSeal vein-closure syste...