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Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER with INTAC.

latest-news

FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder.

LATEST NEWS

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Endo Hit with $2 Billion Fine Over Opioid Sales

Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER with INTAC.

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FDA Denies Approval/Hearing on Vanda Stalled sNDA

FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder.

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FDA Guide on Informed Consent Key Info

FDA posts a draft guidance on “Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards.”

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J&J Gets Full Approval for Rybrevant

FDA grants full approval to Johnson & Johnson’s Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of certain patients with locally advanced or metastatic non-small cell lung cancer

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Animal Drugs

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medical-devices
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2 Veterinary Medicine Guidances Published

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

medical-devices
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Animal Drug API GMP Guidance

FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for animal drug APIs.

medical-devices
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Animal MUMS Drug Guidance

FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.

medical-devices
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Guide on Priority Zoonotic Animal Drugs

FDA posts a draft guidance entitled “Priority Zoonotic Animal Drug (PZAD) Designation and Review Process.”

Biologics

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medical-devices
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Marks Sees ‘Breakout Year’ in Gene Therapy Approvals

CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold to advance product ...

medical-devices
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BeiGene BLA Filed for Gastric Cancer

FDA accepts for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with chemotherapy in treating locally advanced unresectable or me...

medical-devices
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After 2 Earlier Denials, Humira Biosimilar OK’d

FDA approves Alvotech and Teva Pharmaceuticals’ Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVie’s Humira.

medical-devices
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sBLA for Tecvayli OK’d for Reduced Dosing

FDA approves a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patie...

FDA General

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medical-devices
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Supreme Court Could Hit FDA Regulation: FDLI

A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely affect FDA and regu...

medical-devices
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Ex-FDA Lawyer Temkin Joins Paul Hastings

Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin joins Paul Hastings as chair of the firm’s FDA practice.

medical-devices
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Information Technology Operating Plan Posted

The FDA Office of Digital Transformation posts its new IT operating plan and its 2023 annual report.

medical-devices
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Califf on How FDA Addresses Chronic Diseases

FDA commissioner Robert Califf and two of his top associates describe how the agency uses its role to help address common chronic diseases.

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Federal Register

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Antibody-Drug Conjugate Pharmacology Guide

Federal Register notice: FDA makes available a final guidance entitled ‘‘Clinical Pharmacology Consi...

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Device Recognized Consensus Standards Updated

Federal Register: FDA announces a publication containing modifications the agency is making to the l...

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Info Collection for Device User Fee Forms

Federal Register notice: FDA sends to OMB an information collection revision entitled “Medical Devic...

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Info Collection on Device Export Certificates

Federal Register notice: FDA sends to OMB an information collection revision entitled “Export Ce...

Human Drugs

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Endo Hit with $2 Billion Fine Over Opioid Sales

Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties t...

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FDA Denies Approval/Hearing on Vanda Stalled sNDA

FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for H...

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FDA Guide on Informed Consent Key Info

FDA posts a draft guidance on “Key Information and Facilitating Understanding in Informed Consent Gu...

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J&J Gets Full Approval for Rybrevant

FDA grants full approval to Johnson & Johnson’s Rybrevant (amivantamab-vmjw) in combination with che...

Marketing

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Industry Faults FDA Research on DTC ‘Implied Claims’

Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Dru...

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Update FDA Social Media Enforcement: Durbin, Braun

Sens. Durbin and Braun call on FDA to update its prescription ad guidance to reflect the explosion i...

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Panel Backs Abbott’s TriClip PMA

An FDA advisory committee votes 13 to 1 that the benefits of Abbott's TriClip transcatheter edge-to-...

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Think Like a Consumer on DTC Ads: Attorneys

Three SheppardMullin attorneys say a recent Office of Prescription Drug Promotion untitled letter sh...

Medical Devices

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Datex-Ohmeda Air Compressor Recall is Class 1

FDA classifies as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numb...

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Class 1 Correction Recall on Electrodes Updated

FDA updates a Class 1 recall (correction) of Megadyne Medical Products’ Mega Soft patient return ele...

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CDRH Cautions on Breast Implant Removal

CDRH’s Binita Ashar says a recent journal article on breast implant risk provided useful information...

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Electrical OR Table Problems

FDA says it has received reports of rare adverse events involving electrical operating room tables.