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HHS says CBER director Vinay Prasad will step down at the end of April.

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FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an inspection last month.

LATEST NEWS

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FDA Biologics Chief Vinay Prasad to Step Down in April

HHS says CBER director Vinay Prasad will step down at the end of April.

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FDA Cites Documentation Lapses at Maiva Pharma

FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an inspection last month.

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Public Trusts FDA Career Scientists Over Agency Leadership

A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.

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FDA Official Criticizes Advisory Committee Experts

An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who sit on agency advisory committees.

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Animal Drugs

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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.

medical-devices
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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

medical-devices
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Sangamo Begins Rolling BLA for Fabry Gene Therapy

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following result...

Biologics

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medical-devices
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FDA Biologics Chief Vinay Prasad to Step Down in April

HHS says CBER director Vinay Prasad will step down at the end of April.

medical-devices
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FDA Official Pushes Back in UniQure Dispute

A senior FDA official sharply criticizes UniQure’s investigational gene therapy for Huntington's disease, calling it a “failed product” and casting do...

medical-devices
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Regenxbio’s Complete Response Letter Released

FDA posts a complete-response letter that outlined last month's rejection of Regenxbio’s BLA for its gene therapy clemidsogene lanparvovec.

medical-devices
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FDA Wants Randomized Trial for Huntington’s Gene Therapy

FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntington’s disease...

FDA General

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medical-devices
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Public Trusts FDA Career Scientists Over Agency Leadership

A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.

medical-devices
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Guidance Urges Comprehensive Responses to Inspection Findings

FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to ...

medical-devices
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FDA Operations Chief Announces Retirement

FDA deputy commissioner for operations and chief operating officer Barclay Butler announces his retirement in the coming months.

medical-devices
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FDA Overhauls National Drug Codes

FDA finalizes a sweeping overhaul of the National Drug Code system, adopting a standardized 12-digit format for the identifier used to uniquely distin...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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FDA Cites Documentation Lapses at Maiva Pharma

FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility ope...

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FDA Official Criticizes Advisory Committee Experts

An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who ...

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Breakthrough Status for Hemab’s Bleeding Disorder Therapy

FDA grants Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental ther...

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Regulate Outsourcing Ophthalmic Bevacizumab Products: Petition

A Buchanan petition asks FDA to take administrative and enforcement action against 503B outsourcing ...

Marketing

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

Medical Devices

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FDA Flags Expanded Recall of Reprocessed Cardiac Catheters

FDA says an expanded recall by Medline Industries involving certain reprocessed electrophysiology an...

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Petition Asks FDA to Investigate Mayo Robotic Mastectomy

Harmed Americans for Reform in Medical Device Safety petitions FDA to investigate the Mayo Clinic’s ...

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Attorneys Review FDA’s New Inspection Approach for Devices

Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDA’s new ...

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ExThera Regulatory Chief Charged With Concealing Adverse Events

The U.S. Department of Justice charges the former chief regulatory officer at ExThera Medical Corp. ...