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FDA hosts a public meeting next month aimed at exploring ways to expand access to nonprescription medications.

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U.S. Senator Rick Scott (R-FL) urges FDA and other federal health agencies to review and tighten oversight of clinical trials and drug approvals involving Chinese-linked entities, citing potential national security and patient safety risks.

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FDA to Convene Public Meeting on Expanding OTC Drug Access

FDA hosts a public meeting next month aimed at exploring ways to expand access to nonprescription medications.

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Senator Raises Concerns Over Chinese Biotech Firms in U.S. Clinical Trials

U.S. Senator Rick Scott (R-FL) urges FDA and other federal health agencies to review and tighten oversight of clinical trials and drug approvals involving Chinese-linked entities, citing potential national security and patient safety risks.

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FDA OKs Opdivo for Previously Untreated Hodgkin Lymphoma

FDA approves Bristol Myers Squibb’s Opdivo (nivolumab) for use with doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma.

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FDA Schedules Public Hearing on Commissioner’s Voucher Program

FDA is announcing a 6/12 public hearing to gather input on its Commissioner’s National Priority Voucher Pilot Program.

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Animal Drugs

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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.

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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Uncertainty for Gene Therapy, Rare Disease & Vaccines in Prasad Exit Wake

CBER director Vinay Prasad’s departure at the end of next month raises questions across the biotechnology sector about how the agency’s approach to va...

medical-devices
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GSK’s Arexvy RSV Vaccine for High-Risk Adults Ages 18–49

FDA expands the approved use of GSK’s Arexvy, a respiratory syncytial virus accine that now includes the in adults aged 18 to 49 who are at increased ...

medical-devices
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FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season us...

medical-devices
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FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...

FDA General

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medical-devices
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Experts Urge 32 FDA Transparency Reforms in New JAMA Viewpoint

Public health experts call for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent pro...

medical-devices
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FDA Updates Guidance on Pyrogen and Endotoxin Testing

FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater...

medical-devices
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Senators Demand HHS Reverse Autism-Related Web Site Changes

A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccine...

medical-devices
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FDA Updates Internal Procedures for Handling Supplements

FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.

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Federal Register

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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...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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FDA to Convene Public Meeting on Expanding OTC Drug Access

FDA hosts a public meeting next month aimed at exploring ways to expand access to nonprescription me...

motusgi
Read More
Senator Raises Concerns Over Chinese Biotech Firms in U.S. Clinical Trials

U.S. Senator Rick Scott (R-FL) urges FDA and other federal health agencies to review and tighten ove...

motusgi
Read More
FDA OKs Opdivo for Previously Untreated Hodgkin Lymphoma

FDA approves Bristol Myers Squibb’s Opdivo (nivolumab) for use with doxorubicin, vinblastine, and da...

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Read More
FDA Schedules Public Hearing on Commissioner’s Voucher Program

FDA is announcing a 6/12 public hearing to gather input on its Commissioner’s National Priority Vouc...

Marketing

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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...

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

Medical Devices

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Warning Letter Cites ‘Right-to-Try’ Law

Two Mintz attorneys say a CDRH Warning Letter to a medical device sponsor of clinical research and c...

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LivaNova PMA OK’d for Sleep Apnea

FDA approves a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat ad...

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Multiple Avertix Medical Violations Cited

FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Co...

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Some Agreements in MDUFA 6 Negotiations

Minutes from two February MDUFA 6 negotiating sessions show areas of agreement between FDA and indus...