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A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize the availability of smartphone technology and QR codes.

latest-news

Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health technologies in clinical trials.

LATEST NEWS

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Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer disclaimer rules to recognize the availability of smartphone technology and QR codes.

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FDA Seeking Input on Expanding Digital Health Tech in Trials

Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health technologies in clinical trials.

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CGMP Deviations in Henan Lvyuan Inspection

FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from current good manufacturing practices for active pharmaceutical ingredients.

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NIH-Funded Study to Assess GLP-1 Drugs in Alzheimer’s

Researchers at the University of Cincinnati begin a new study to investigate whether widely used diabetes and weight-loss drugs could help prevent or delay Alzheimer’s disease.

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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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Novel CAR-T Therapy Gets Breakthrough Status

A novel “off-the-shelf” CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receives an FDA breakthro...

medical-devices
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FDA Crackdown on CAR-T Promotion in Coordinated Action

In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signaling heightened scrut...

medical-devices
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FDA Grants Accelerated Approval to Rocket’s Gene Therapy

FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children with severe Leukocyte ...

medical-devices
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Ocugen Reports Positive Phase 2 Data for Vision Loss Gene Therapy

Ocugen announces positive 12-month results from a mid-stage clinical trial of its experimental gene therapy OCU410, aimed at treating geographic atrop...

FDA General

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medical-devices
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FDA Seeking Input on Expanding Digital Health Tech in Trials

Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health technologies in cli...

medical-devices
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Scholar Rock Refiles BLA for Spinal Muscular Atrophy Therapy

Scholar Rock resubmits its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy.

medical-devices
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Editorial Criticizes Makary Over Leadership Decisions

The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

medical-devices
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More Conflict of Interest Transparency Needed: GAO

The Government Accountability Office recommends that FDA take steps to publicly disclose how it resolves conflict of interest and appearance issues fo...

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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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CGMP Deviations in Henan Lvyuan Inspection

FDA warns Henan, China-based Henan Lvyuan Pharmaceutical Company about significant deviations from c...

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NIH-Funded Study to Assess GLP-1 Drugs in Alzheimer’s

Researchers at the University of Cincinnati begin a new study to investigate whether widely used dia...

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FDA Says Proposed Drug Import Guidance ‘Unwarranted’

FDA denies a 2024 Aimed Alliance petition asking for a guidance on human drug importation by alterna...

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FDA-483 Not a Proxy for Overall Quality: Califf

Former FDA commissioner Robert Califf says form FDA-483 is a useful regulatory tool for identifying ...

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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FDA Guide on Patient Preferences in Device Submissions

FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Ov...

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Medtronic Wins Expanded Clearance for AXiS System

Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and th...

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FDA Flags Recall of Erbe Flexible Cryoprobes Over Rupture Hazard

Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which ...

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Multiple Violations at Longhorn Vaccines and Diagnostics

FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device ...