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Law firm Sheppard breaks down some of FDA’s proposals in its budget documents that industry should keep a close eye on, including new DTC ad authorities that signal enforcement will likely intensify under this administration.

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A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments.

LATEST NEWS

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FDA Budget Proposal Signals Push for Tighter Ad Oversight

Law firm Sheppard breaks down some of FDA’s proposals in its budget documents that industry should keep a close eye on, including new DTC ad authorities that signal enforcement will likely intensify under this administration.

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FDA Not Keeping Pace with Non-Oncology Basket Trials: Column

A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments.

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Mass Compounding Threatens FDA Enforcement: Column

An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.

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Insmed Halts Brensocatib Program After Mid-Stage Trial Miss

Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints.

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Animal Drugs

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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.

medical-devices
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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

Biologics

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medical-devices
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Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.

medical-devices
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Positive Phase 3 Date for Subcutaneous Tepezza: Amgen

Amgen reports positive topline results from a Phase 3 trial evaluating a subcutaneous version of its thyroid eye disease drug Tepezza (teprotumumab-tr...

medical-devices
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FDA Flags Quality System Gaps at CSL Behring Site

FDA posts a Form 483 that identifies deficiencies in quality system procedures at a manufacturing facility operated by CSL Behring GmbH in Marburg, Ge...

medical-devices
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CBER File Over Protest SOPP

CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.

FDA General

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medical-devices
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FDA Budget Proposal Signals Push for Tighter Ad Oversight

Law firm Sheppard breaks down some of FDA’s proposals in its budget documents that industry should keep a close eye on, including new DTC ad authoriti...

medical-devices
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Doctor Failed to Follow Investigational Plan: FDA

FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.

medical-devices
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FDA Budget Request Seeks 3% Increase

FDA’s just-released proposed fiscal year 2027 budget seeks a 3.3% increase or about $200 million to fund the agency’s operations.

medical-devices
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FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments

FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatm...

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Federal Register

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Mitapivat Moving Toward Accelerated Approval in Sickle Cell: Agios

Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell diseas...

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

Human Drugs

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FDA Not Keeping Pace with Non-Oncology Basket Trials: Column

A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kep...

motusgi
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Mass Compounding Threatens FDA Enforcement: Column

An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved dr...

motusgi
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Insmed Halts Brensocatib Program After Mid-Stage Trial Miss

Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after...

motusgi
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See Supply Chain Strategy as Core Regulatory Function: Attorney

Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S...

Marketing

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Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer d...

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Influencers’ Drug Promotions Pose Public Health Risks: JAMA

A new study published in JAMA Network Open highlights growing public health concerns over prescripti...

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Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of J...

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FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer pr...

Medical Devices

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Medline Industries QS Violations Cited

FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufactur...

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FDA Opens READI-Home Innovation Challenge

FDA solicits applications for its new READI-Home innovation challenge to use medical technology in t...

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FDA Patient Preference Guide Addresses 510(k) Applicability

FDA’s updated guidance on how patient preference information can be incorporated into regulatory dec...

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Anumana Pulmonary Hypertension AI Tool Wins Clearance

FDA clears an Anumana 510(k) for an artificial intelligence–based tool designed to detect early sign...