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FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovascular procedure kits.

latest-news

Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowering prescription drug costs by curbing patent practices and preserving generic competition.

LATEST NEWS

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Medline Industries QS Violations Cited

FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovascular procedure kits.

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Groups Urge Congress to Advance Generic Drug Bills

Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowering prescription drug costs by curbing patent practices and preserving generic competition.

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FDA Grants Outlook Therapeutics’ Dispute Resolution Request

FDA agrees to hear an Outlook Therapeutics formal dispute resolution request regarding the agency’s prior rejection of eye disease therapy Lytenava (bevacizumab-vikg).

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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.

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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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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...

medical-devices
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HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns

HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...

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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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Groups Urge Congress to Advance Generic Drug Bills

Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisa...

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FDA Grants Outlook Therapeutics’ Dispute Resolution Request

FDA agrees to hear an Outlook Therapeutics formal dispute resolution request regarding the agency’s ...

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Support for Rare Disease Education Materials

Three stakeholders express support for FDA’s LEADER 3D rare disease educational materials and sugges...

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Workshop on Improving Pregnancy Drug Safety Registries

FDA plans a two-day public workshop next month aimed at improving how pregnancy registries are desig...

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...