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The Department of Justice says a federal grand jury has indicted the co-owner of Florida’s Pine Care Research Center and two staff members on charges they falsified clinical trial data.

latest-news

Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing concern about the nation’s ability to respond to Ebola and other global health crises.

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Doctor, Staff Charged with Falsifying Trial Data

The Department of Justice says a federal grand jury has indicted the co-owner of Florida’s Pine Care Research Center and two staff members on charges they falsified clinical trial data.

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17 Senate Democrats Hit HHS on FDA, Other Changes

Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing concern about the nation’s ability to respond to Ebola and other global health crises.

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Risk Management an “Ever-Evolving Responsibility”: Thomas

CDRH associate director for compliance and quality Keisha Thomas tells the RAPS Quality Conference about FDA’s new Quality Management System Regulation.

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Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda

Takeda says its investigational TYK2 inhibitor zasocitinib performed significantly better than Bristol Myers Squibb’s Sotyktu in a Phase 3 head-to-head psoriasis trial.

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Animal Drugs

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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 ...

medical-devices
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White House Reportedly Moves to Oust Commissioner Makary

Several media outlets report that President Trump has signed off on a plan to remove FDA commissioner Marty Makary from his post.

Biologics

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medical-devices
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FDA Approves Lupin's Interchangeable Lucentis Biosimilar

FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis.

medical-devices
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FDA Orders Takeda to Add Boxed Warning to Adzynma

FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, a...

medical-devices
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CBER Post New E-Submission Frequently Asked Questions Guide

FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for products regulated b...

medical-devices
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Replimune to Refile Controversial Melanoma BLA

Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma ...

FDA General

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medical-devices
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17 Senate Democrats Hit HHS on FDA, Other Changes

Some 17 Senate Democrats write to HHS secretary Robert F. Kennedy Jr., questioning many of his personnel decisions and expressing concern about the na...

medical-devices
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FDA Cites Formulated Solutions Over Manufacturing, Quality

FDA sends an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and quality oversight a...

medical-devices
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AMA Delegates Call for Tighter FDA Oversight of Unapproved Peptides

Delegates at the American Medical Association's annual meeting vote to support stronger FDA oversight of synthetic peptide products, citing growing co...

medical-devices
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FDA AI Inspections Prompts Industry Readiness Strategy Rethink

Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools.

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Federal Register

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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...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

Human Drugs

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Doctor, Staff Charged with Falsifying Trial Data

The Department of Justice says a federal grand jury has indicted the co-owner of Florida’s Pine Care...

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Read More
Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda

Takeda says its investigational TYK2 inhibitor zasocitinib performed significantly better than Brist...

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CGMP Violations Seen in Port Jervis Records Review

FDA cautions Port Jervis Laboratories in Port Jervis, NY, about CGMP violations in its manufacturing...

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Congressional Report Outlines FDA Oversight of AI-Enabled Devices

A new Congressional Research Service report outlines FDA’s evolving approach to regulating artificia...

Marketing

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FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease ...

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FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in p...

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DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

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Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

Medical Devices

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Risk Management an “Ever-Evolving Responsibility”: Thomas

CDRH associate director for compliance and quality Keisha Thomas tells the RAPS Quality Conference a...

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Early Alert on Baxter Volara Breathing Device Circuits

FDA issues an early alert regarding a potentially high-risk issue affecting certain patient circuits...

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Alert on GE HealthCare Infant Resuscitation Systems

FDA issues an early alert warning healthcare providers about a potentially high-risk defect affectin...

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FDA Breakthrough Device Designations Top 1,280

FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlig...