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FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable magnesium scaffold, intended for use in individuals suffering from chronic limb-threatening ischemia.

latest-news

Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices.

LATEST NEWS

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Biotronik Breakthrough Status for Freesolve Device

FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable magnesium scaffold, intended for use in individuals suffering from chronic limb-threatening ischemia.

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Sleepnet Recalls Sleep Apnea Masks

Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain 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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

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Eugia Inspection Results in 7-Item FDA 483

A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.’s Telangana, India sterile drug manufacturing facility results in a seven-item Form FDA 483.

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Animal Drugs

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FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”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

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.

Biologics

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medical-devices
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Orchard’s Leukodystrophy Gene Therapy OK’d

FDA approves an Orchard Therapeutics BLA for Lenmeldy (atidarsagene autotemcel), a one-time, single-dose gene therapy indicated for treating children ...

medical-devices
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FDA OK’s Hugel’s Frown Lines Neurotoxin

FDA approves Hugel’s Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults.

medical-devices
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Oregon Medical Cited Over Social Media Claims

CBER cites Oregon Medical Centers in an untitled letter over claims it is making on social media sites Facebook and Youtube about its cellular product...

medical-devices
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‘Fresh Allograft Heart Valves’ Regulated by FDA

FDA affirms its regulation of “fresh allograft heart valves” in a just-posted letter to healthcare professionals.

FDA General

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medical-devices
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FDA Paper on AI Targets 4 Focus Areas

FDA posts a cross-Center paper entitled “Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” that ide...

medical-devices
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FDA Budgets to Expand ‘Foreign Footprint’

FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its foreign operations.

medical-devices
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$500 Million Boost to FDA in President’s Budget Proposal

President Biden seeks a $500 million boost in FDA’s spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion spending level in F...

medical-devices
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Budget Compromise Gives FDA $160 Million Boost

Senate and House appropriators post a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 million (2.4%) budget boos...

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Federal Register

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Bayer’s Aliqopa Withdrawn Over Failed Confirmation

Federal Register notice: FDA withdraws the approval of Bayer’s NDA for Aliqopa (copanlisib) in respo...

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Guidance on Generic Drug Controlled Correspondence

FDA posts a final guidance entitled “Controlled Correspondence Related to Generic Drug Development.”

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Date Correction in Alzheimer’s Guidance

Federal Register notice: FDA corrects a date in a 3/12 notice announcing the availability of a guida...

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Device Q-Submission Feedback Draft Guidance

Federal Register notice: FDA makes available a draft guidance entitled “Requests for Feedback and Me...

Human Drugs

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Biotronik Breakthrough Status for Freesolve Device

FDA grants Biotronik a beakthrough device designation for the Freesolve below-the-knee resorbable ma...

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Sleepnet Recalls Sleep Apnea Masks

Sleepnet recalls its CPAP and BIPAP sleep apnea masks with magnets due to potential interference wit...

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Eugia Inspection Results in 7-Item FDA 483

A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.’s Telangana, India sterile drug manufactur...

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GSK Reports Favorable Jemperli Phase 3 Data

GSK reports favorable overall survival and progression-free survival data in a Phase 3 trial involvi...

Marketing

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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...

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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-...

Medical Devices

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FDA Guidance on Device Thermal Effects

FDA publishes a draft guidance on the information that should be in medical device premarket submiss...

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Updated Draft Q-Submission Guidance

FDA publishes for comment an updated draft guidance on requesting feedback and meetings with FDA on ...

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Ortho Trivicta Hip System Cleared

FDA clears an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that...

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Medos Recalls Cerebase DA Guide Sheath

Johnson & Johnson’s Medos International Sarl device unit recalls its Cerebase DA Guide Sheath after ...