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

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FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.

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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.

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PolyPid NDA Accepted for Preventing Surgical Site Infection

FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.

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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.

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9 Items on Bentley Laboratories FDA-483

FDA releases the form FDA-483 with nine observations from an inspection at the Edison, NJ-based Bentley Laboratories over-the-counter drug manufacturing facility.

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Animal Drugs

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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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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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FDA Panel Votes Down Capricor's Duchenne Cell Therapy

An FDA advisory committee votes against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, for treating cardiom...

medical-devices
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CBER Offers Tips for Cell/Gene Therapy BLA Submissions

CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well befor...

medical-devices
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J&J Reports Positive Data From Multiple Myeloma Study

Johnson & Johnson reports promising topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqy...

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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PolyPid NDA Accepted for Preventing Surgical Site Infection

FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infe...

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9 Items on Bentley Laboratories FDA-483

FDA releases the form FDA-483 with nine observations from an inspection at the Edison, NJ-based Bent...

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Dr. Reddy’s Gets FDA-483 After Pre-Approval Inspection

FDA issues Dr. Reddy’s a three-observation Form FDA-483 following a pre-approval inspection and Good...

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New Effectiveness Evidence Requirements Analyzed

Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evide...

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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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...

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Linemaster Switch QS Violations

FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its product...

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FDA Early Alert Over Boston Scientific Transcarotid Catheter Systems

FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Bost...