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A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

latest-news

During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriched enrollment studies for opioid products from now on.

LATEST NEWS

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FDA Leaders’ Financial Ties to Drug Industry Probed

A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

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No More Opioid Enriched Enrollment Studies: Califf

During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriched enrollment studies for opioid products from now on.

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Device Lawyers Urge SCOTUS to Hear Off-Label Appeal

DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decision upholding the conviction of two former Acclarent executives on misdemeanor charges of distributing misbranded and adulterated medical devices.

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FDA Defines Device ‘Remanufacturing’

FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.

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Animal Drugs

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medical-devices
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Mass Spectrometry Guide for Animal Drugs

FDA posts a final guidance entitled “Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.”

medical-devices
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Pediatric Brain Tumor Therapy Approved

FDA grants Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age an...

medical-devices
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Guide on Animal Drug Mfg. Batches

FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

medical-devices
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2 Veterinary Medicine Guidances Published

The Center for Veterinary Medicine issues two guidances on data element submission.

Biologics

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medical-devices
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Exocel Bio Selling Unapproved Exosomes: FDA

FDA says Exocel Bio in San Diego is marketing unapproved exosome products.

medical-devices
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BLA Accepted for Subcutaneous Opdivo

FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumo...

medical-devices
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Marks OK with ‘Some’ Gene Accelerated Approval Mistakes

CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.

medical-devices
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Lilly Gets 6/10 Panel Date for Alzheimer’s BLA

FDA announces a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for Alzheimer’s drug donanemab...

FDA General

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medical-devices
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FDA Leaders’ Financial Ties to Drug Industry Probed

A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

medical-devices
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Hearing to Grill FDA Center Directors

The House Energy and Commerce Committee announces a 5/22 hearing titled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices,” which w...

medical-devices
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J&J Reports Favorable TAR-200 Clinical Data

A Phase 2b clinical study evaluating Johnson & Johnson’s investigational TAR-200 monotherapy in non–muscle-invasive bladder cancer patients with carci...

medical-devices
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WSJ ‘Apologizes’ for Supporting Califf

An unusually strident Wall Street Journal editorial apologizes to its readers for supporting FDA commissioner Robert Califf’s appointment now that he’...

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Federal Register

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‘Party Drug’ MDMA Goes to Panel for PTSD

Federal Register notice: FDA announces a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to...

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Guide on REMS Logic Model

Federal Register notice: FDA makes available a draft guidance entitled “REMS Logic Model: A Framewor...

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12 No-Longer-Marketed ANDAs Withdrawn

Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they noti...

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Test Emergency Policies Under Sec. 564 Guide

Federal Register notice: FDA makes available a draft guidance entitled “Consideration of Enforcement...

Human Drugs

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No More Opioid Enriched Enrollment Studies: Califf

During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agen...

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RAPT Unblinding Data in Trials on Clinical Hold

RAPT Therapeutics closes and unblinds two Phase 2 trials of zelnecirnon following FDA clinical holds...

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BIO on Collecting Race, Ethnicity Data

BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in...

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ORA Reorg’s Impact on Drug Inspections: Cavazzoni

CDER director Patrizia Cavazzoni provides an update on the reorganization of FDA’s Office of Regulat...

Marketing

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Biological Promotion Q&A Guidance

FDA publishes a draft guidance with questions and answers on promotional communications for some pre...

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Methodological Rigor Info May Help Promotions: OPDP

CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in commun...

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Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and ...

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Digital Drug Marketing Workshop Themes

A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital...

Medical Devices

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Device Lawyers Urge SCOTUS to Hear Off-Label Appeal

DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decisi...

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FDA Defines Device ‘Remanufacturing’

FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing an...

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Vyaire Recalls Exercise Test Component

Vyaire Medical recalls (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, whi...

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FDA on Ongoing Getinge Device Concerns

FDA reminds healthcare providers and facilities about the agency’s continuing safety and quality con...