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FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chosen to participate in the new Expedited IND Pilot program.

latest-news

CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device reviews and regulatory decisions to streamline their own oversight and potentially accelerate devices to market.

LATEST NEWS

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FDA Taking Expedited IND Pilot Applications

FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chosen to participate in the new Expedited IND Pilot program.

motusgi
FDA Launches Medical Device Regulatory Reliance Portal

CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device reviews and regulatory decisions to streamline their own oversight and potentially accelerate devices to market.

motusgi
Psychedelic Drug Hearing Focuses on Access, Safety

Stakeholders stress issues involving access and safety at an FDA hearing on psychedelic drug regulation.

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FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial

FDA agrees to key elements of Rocket Pharmaceuticals’ modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the company to continue enrollment and dosing and potentially use the study to support accelerated approval.

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Animal Drugs

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medical-devices
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Antimicrobial Animal Drug Finalized Safety Guidance

FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

medical-devices
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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...

Biologics

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medical-devices
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FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial

FDA agrees to key elements of Rocket Pharmaceuticals’ modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the company to continue en...

medical-devices
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Scholar Rock’s Spinal Muscular Atrophy Therapy Approved

FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.

medical-devices
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Nanoscope BLA Accepted for Vision Restoration Gene Therapy

FDA accepts for review a Nanoscope Therapeutics BLA seeking approval for Mogenry, an optogenetic gene therapy designed for vision restoration in patie...

medical-devices
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Bioresearch Monitoring Violations Found

FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an investigational prod...

FDA General

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medical-devices
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Cassidy Remains Noncommittal on Overton FDA Nomination After Meeting

Senate HELP Committee chairman Bill Cassidy (R-La.) keeps mum on any potential support for FDA commissioner nominee Heidi Overton following a meeting ...

medical-devices
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FDA Seeks Input on Statistical Flexibility in Rare Disease Trials

FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, including when the agency mi...

medical-devices
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FDA Needs Workforce Rebuilding, Less Political Interference: Sinha

Saint Louis University law professor Michael S. Sinha says FDA’s next commissioner should focus on rebuilding the agency’s depleted workforce, restori...

medical-devices
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FDA-SEC Info Sharing Raises Disclosure, Insider Trading Concerns

A Sheppard analysis warns that regulated industry should expect closer scrutiny of statements about FDA interactions and broaden their insider-trading...

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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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FDA Taking Expedited IND Pilot Applications

FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified resear...

motusgi
Read More
Psychedelic Drug Hearing Focuses on Access, Safety

Stakeholders stress issues involving access and safety at an FDA hearing on psychedelic drug regulat...

motusgi
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Bill to Make Pediatric Rare Disease Voucher Permanent

Six House members introduce bipartisan legislation to make the FDA Rare Pediatric Disease Priority R...

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CGMP Issues at Bausch and Lomb Tampa Facility

FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.

Marketing

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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigationa...

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FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDA’s intensified scrutiny of drug ...

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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...

Medical Devices

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FDA Launches Medical Device Regulatory Reliance Portal

CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device r...

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BMC Medical Recalls Sleep Apnea Machines

BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure mach...

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GenAI Devices to See Increased Scrutiny: Law Firm

A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled ...

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Heartvue’s MRI-Reviewing Software Cleared

FDA grants Heartvue.ai a 510(k) clearance for its Heartvue.Proton, a machine learning–powered softwa...