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FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.

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FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.

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Dabur India CGMP Violations

FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.

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Quality System Issues at Koven Technologies

FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.

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Multiple Violations in Brunner Hygiene Unapproved New Drugs

FDA warns Germany’s Thomas Brunner Hygiene about CGMP and other violations in its production of unapproved and misbranded antiperspirants.

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Jazz to Remove Zepzelca Second-Line Indication

Jazz Pharma says it will seek FDA approval to remove Zepzelca’s (lurbinectedin) second-line metastatic small cell lung cancer indication based on data from the company’s LAGOON trial.

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Animal Drugs

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medical-devices
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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

Biologics

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medical-devices
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Allergan sBLA for Botox Accepted for Review

FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance...

medical-devices
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Draft Guidance on Biosimilar Container Closure Design

A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and in...

medical-devices
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Sen. Johnson Wants Covid Interviews with Former FDAers, Fauci

Sen. Ron Johnson asks to interview four former CBER officials and Anthony Fauci on the safety and efficacy of Covid vaccines.

medical-devices
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Rybrevant Faspro sBLA Gets Priority Review for Head & Neck Cancer

FDA accepts for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro for adults with recurrent or metastatic head an...

FDA General

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medical-devices
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FDA Posts User Fee Rates for FY 2027

FDA posts the following user fee rates for medical product programs for fiscal year 2027.

medical-devices
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Dr. Oz Emerges as Potential Successor to RFK Jr. at HHS, Report Says

Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administration as the leading c...

medical-devices
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FDA Moving to a ‘Shared Services’ and Inspections Approach

NOTUS reports that FDA will reorganize on 10/1 to a “shared services” model in which administrative functions are centralized, and inspectors are gene...

medical-devices
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FDA Advisers Back Expanded Access to Several Compounded Peptides

An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the agency's Section 503A ...

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

Human Drugs

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Dabur India CGMP Violations

FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.

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Multiple Violations in Brunner Hygiene Unapproved New Drugs

FDA warns Germany’s Thomas Brunner Hygiene about CGMP and other violations in its production of unap...

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Jazz to Remove Zepzelca Second-Line Indication

Jazz Pharma says it will seek FDA approval to remove Zepzelca’s (lurbinectedin) second-line metastat...

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FDA Aims to Modernize Inspection Program

FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based...

Marketing

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respi...

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Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the ...

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DTC Advertising Industry Braces for Potential End of Adequate Provision

DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provi...

Medical Devices

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Quality System Issues at Koven Technologies

FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketin...

motusgi
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FDA Finalizes Updated Device Human Factors Guidance

FDA issues an updated final guidance entitled “Applying Human Factors and Usability Engineering to M...

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Resmed Class 1 Recall of Astral Ventilators

Resmed recalls its Astral 100/150 ventilator system due to the potential for a supercapacitor electr...

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FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology

FDA grants de novo authorization for Caristo Diagnostics’ CaRi-Heart coronary inflammation technolog...