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FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Committee to confirm the benefits and risks of Eisai/Biogen’s Leqembi in treating early Alzheimer’s disease.

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Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information would represent a significant change in drug labeling.

LATEST NEWS

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Eisai/Biogen Alzheimer’s Drug Effective: FDA

FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Committee to confirm the benefits and risks of Eisai/Biogen’s Leqembi in treating early Alzheimer’s disease.

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PMI ‘Major Change’ in Drug Labeling: Attorneys

Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information would represent a significant change in drug labeling.

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Bioresearch Monitoring Issues in Mazhar Trials

FDA warns Houston, TX-based physician Mobeen Mazhar about violations in conducting three clinical trials.

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CBER Post-Covid Transition Information

CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emergency.

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Animal Drugs

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FDA/EU MRA Now Includes Animal Inspections

FDA and the European Union agree to expand the scope of the U.S.-EU mutual recognition agreement to include inspections of veterinary pharmaceuticals.

medical-devices
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Complete Response on Bladder Cancer BLA

FDA sends ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating certai...

medical-devices
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FDA, NIST Animal Product Resource Development

FDA announces a joint project with the National Institute of Standards and Technology to develop resources needed by animal biotechnology developers.

medical-devices
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CVM Electronic Submission Registration

FDA publishes a guidance with general standards for registering with the CVM electronic submission system.

Biologics

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medical-devices
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CBER Post-Covid Transition Information

CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emergency.

medical-devices
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Legend Bio sBLA to Expand Carvykti’s Use

Legend Biotech files a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patient...

medical-devices
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GSK File sBLA for Jemperli in Endometrial Cancer

FDA accepts for review a GSK supplemental BLA for Jemperli (dostarlimab) in combination with chemotherapy for treating certain adult patients with adv...

medical-devices
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Kyverna Gets Fast Track for Lupus Nephritis Drug

FDA grants Kyverna Therapeutics a fast track designation for KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for treating patients with...

FDA General

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medical-devices
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FDA Struggles to Recruit in Wake of Retirements

FDA chief of staff Julie Tierney says the agency is experiencing a larger-than-normal exodus of retiring employees now that the Covid-19 public health...

medical-devices
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CDER Drug Policy Guru Heads to Morgan Lewis

CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a partner resident.

medical-devices
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New FDA MOU for Distributed Manufacturing

FDA and the Veterans Health Administration announce a new memorandum of understanding to advance distributed manufacturing and digital stockpiles for ...

medical-devices
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Appropriators Cut FDA Budget by $600 million

A House Appropriations Subcommittee cuts FDA’s fiscal year 2024 budget request by $600 million (8.3%).

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Federal Register

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ICH Guide on Good Clinical Practice

Federal Register notice: FDA makes available a draft guidance entitled “E6(R3) Guideline for Good Cl...

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Braun EUA Revoked on Propofol-Lipuro

Federal Register notice: FDA revokes an emergency use authorization issued to B. Braun Melsungen AG ...

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Guide on ANDA Cover Letter Attachments

Federal Register notice: FDA makes available a final guidance entitled “Cover Letter Attachments for...

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FDA Withdraws Approval of Vintage Pharma ANDA

Federal Register notice: FDA withdraws approval of a Vintage Pharmaceuticals ANDA for pemoline table...

Human Drugs

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Eisai/Biogen Alzheimer’s Drug Effective: FDA

FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Commit...

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PMI ‘Major Change’ in Drug Labeling: Attorneys

Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information w...

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Read More
Bioresearch Monitoring Issues in Mazhar Trials

FDA warns Houston, TX-based physician Mobeen Mazhar about violations in conducting three clinical tr...

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FibroGen’s Pamrevlumab Fails Phase 3

FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dyst...

Marketing

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More Groups, Experts Back KEI Ad Music Petition

Three stakeholder groups and seven individuals call for FDA to promptly approve a Knowledge Ecology ...

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Regulators Need to Keep Up with ‘Patient Influencers’: Study

A new University of Colorado Boulder study points to the need for FDA to work harder to follow and c...

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Drug Promotion Research Landscape Analyzed

FDA and RTI International researchers review empirical studies of prescription drug promotion in the...

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Lower Added Benefit Associated with Higher DTC Spend

Johns Hopkins University researchers say spending on direct-to-consumer ads in 2020 was associated w...

Medical Devices

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AdvaMed Recommendations for Patient Preference

AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient ...

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Teleflex Pacing Guidewire Cleared

FDA clears a Teleflex 510(k) for its Wattson Temporary Pacing Guidewire – a bipolar temporary device...

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Multiple Violations at Steiner Biotechnology

FDA warns Henderson, NV-based Steiner Biotechnology about multiple violations in its production and ...

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iRhythm Technologies Cited for Unapproved Device

FDA warns Cypress, CA-based iRhythm Technologies about multiple violations in its production of the ...