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FDA Announces Moves to Fast-Track Psychedelic Therapies

FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from president Trump that directed federal health agencies to expand access to emerging therapies.

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Human Drugs

Global Calcium FDA-483 Has 6 Observations

FDA releases a form FDA-483 with six observations from an inspection at India’s Global Calcium active pharmaceutical ingredient manufacturing facility.

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Human Drugs

FDA Announces Moves to Fast-Track Psychedelic Therapies

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Human Drugs

Revive Rx FDA-483 Has 5 Repeat Observations

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FDA General

Loper Bright Affecting Regulation of Synthetic Biology: Column

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Human Drugs

Agency Rejects Grace Therapeutics’ GTx-104 NDA

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FDA Announces Moves to Fast-Track Psychedelic Therapies

FDA announces several actions aimed at accelerating the development of treatments for serious mental illness, following a recent executive order from president Trump that directed federal health agencies to expand access to emerging therapies.

motusgi
Global Calcium FDA-483 Has 6 Observations

FDA releases a form FDA-483 with six observations from an inspection at India’s Global Calcium active pharmaceutical ingredient manufacturing facility.

motusgi
Ban Mercury Amalgam Fillings: Petition

Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerable populations.

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Gene Therapy Approved for Inherited Hearing Loss

FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.

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Animal Drugs

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Lilly to Seek FDA Approval for Foundayo in Diabetes

Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...

medical-devices
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2 CDER Postmarketing MAPPS Out

CDER issues two revised Manuals of Policies and Procedures relating to developing and communicating postmarketing requirements and commitments.

medical-devices
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Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

medical-devices
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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

Biologics

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medical-devices
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FDA Accepts Roche sBLA for Gazyva in Lupus

FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.

medical-devices
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Eye Doctor Emerges as Contender for CBER Head

FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBER’s next director.

medical-devices
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FDA rejects Replimune Melanoma Therapy Again

FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for ad...

medical-devices
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Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis product ReNu.

FDA General

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medical-devices
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Gene Therapy Approved for Inherited Hearing Loss

FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.

medical-devices
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Loper Bright Affecting Regulation of Synthetic Biology: Column

A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDA’s regulatory framework under the Supreme Court’s Loper Bright ...

medical-devices
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FDA Approves Merck’s Idvynso for Treating HIV

FDA approves Merck’s Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.

medical-devices
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Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava

Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the company’s push to revive its approval prospects for ONS-501...

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Federal Register

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Padcev-Keytruda Combo for Broader Bladder Cancer

FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortuma...

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FDA Streamlined Compliance Policy for Certain Respirators

FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket...

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Phillips Ventilator Correction is Class 1 Recall

FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recal...

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FDA Updates Compliance Program for Biologic Drug Manufacturers

FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing fac...

Human Drugs

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FDA Announces Moves to Fast-Track Psychedelic Therapies

FDA announces several actions aimed at accelerating the development of treatments for serious mental...

motusgi
Read More
Global Calcium FDA-483 Has 6 Observations

FDA releases a form FDA-483 with six observations from an inspection at India’s Global Calcium activ...

motusgi
Read More
FDA Not Pursuing Ban on Drug DTC Ads, Makary says

FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharma...

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High-Risk Issue With Angiographic Syringes in Surgical Kits: FDA

FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certa...

Marketing

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Will the Push for DTC Pre-Review Grow?

Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congres...

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Alymsys Patient Brochure False or Misleading: FDA

The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosi...

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Lucemyra Web Site Home Page False or Misleading: FDA

FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucem...

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Modernize DTC Ads with QR Code: WLF

A Washington Legal Foundation background document suggests that Congress change direct-to-consumer d...

Medical Devices

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Ban Mercury Amalgam Fillings: Petition

Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercu...

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FDA, CMS Unveil ‘RAPID’ to Speed Device Coverage Decisions

FDA and CMS unveil a new joint initiative aimed at significantly shortening the time it takes for in...

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FDA Denies Petition to Withdraw Approval of VenaSeal

FDA denies a citizen petition seeking to withdraw approval of Covidien’s VenaSeal vein-closure syste...

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Philips Wins Clearance for AI-powered Spectral CT System

FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as th...