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FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

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Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are likely to run afoul of FDA’s crackdown on such ads.

LATEST NEWS

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Novo Nordisk PADE Reporting Violations

FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

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FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are likely to run afoul of FDA’s crackdown on such ads.

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CGMP Violations at Fareva Morton Grove

FDA warns France’s Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility.

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Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement action against Hims & Hers for its Super Bowl TV ad promoting unapproved compounded drugs through unsubstantiated and misleading claims.

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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 Flags Safety Reporting Lapses at U.K. Clinical Trial Site

FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...

medical-devices
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Updated Guidance Clarifies Biosimilar Development Requirements

FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

medical-devices
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Incyte Gets ‘Complete Response’ Over Catalent Inspection Issues

FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspection findings (not spec...

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.

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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Novo Nordisk PADE Reporting Violations

FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug exper...

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CGMP Violations at Fareva Morton Grove

FDA warns France’s Fareva about CGMP violations in the production of finished drugs at its Morton Gr...

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FDA OKs Leucovorin for Ultra-Rare Brain Disorder, But Not Autism

FDA approves an expanded use of GSK’s Wellcovorin (leucovorin calcium) tablets for treating cerebral...

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CGMP Issues at Simtra BioPharma Solutions

FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufact...

Marketing

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FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer pr...

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Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of J...

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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...

Medical Devices

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FDA Issues Early Alert on Erbe Flexible Cryoprobes

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprob...

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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 ...