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The Washington Legal Foundation cautions that the Trump administration’s ongoing crackdown on direct-to-consumer pharmaceutical advertising is on a collision course with First Amendment protections.

latest-news

The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug under a so-called “skinny label.”

LATEST NEWS

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WLF Warns on New DTC Ad Rules Violating First Amendment

The Washington Legal Foundation cautions that the Trump administration’s ongoing crackdown on direct-to-consumer pharmaceutical advertising is on a collision course with First Amendment protections.

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DoJ urges High Court Review of ‘Skinny-Label’ Dispute

The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug under a so-called “skinny label.”

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No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time to first agency postmarket safety action for novel therapeutics.

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Revoke All mRNA Covid Vaccine BLAs: CHD Petition

Children’s Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not comply with BLA requirements for clinical trials and are mislabeled, misbranded, and potentially adulterated.

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Animal Drugs

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medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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medical-devices
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Revoke All mRNA Covid Vaccine BLAs: CHD Petition

Children’s Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not comply with BLA req...

medical-devices
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HCT/P Violations at Ponya Therapeutics

FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and tissue-based produc...

medical-devices
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FDA Raises Approval Standards for CAR-T Cancer Therapies

CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on single-arm studies ...

medical-devices
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FDA Broadens Covid Vaccine Probe to Include Adult Deaths

FDA opens a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines after probing pediatric deaths allegedly ti...

FDA General

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medical-devices
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Experts Call for Overhaul of FDA ‘Revolving Door’ Rules

Two pharmacist-attorneys (BakerHostetler) urge Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles,...

medical-devices
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Biden Admin Buried Covid Myocarditis Data: Makary

FDA commissioner Marty Makary alleges that the Biden administration failed to disclose internal data on myocarditis risks in young people following Co...

medical-devices
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Former FDA Heads Warn on Prasad’s New Vaccine Policies

A dozen former FDA commissioners warn that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evidence-based vaccine ...

medical-devices
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Guidance to Update Manufacturing Standards for Medical Gases

FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.

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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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WLF Warns on New DTC Ad Rules Violating First Amendment

The Washington Legal Foundation cautions that the Trump administration’s ongoing crackdown on direct...

motusgi
Read More
DoJ urges High Court Review of ‘Skinny-Label’ Dispute

The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide wheth...

motusgi
Read More
No FDAAA Difference in Time to 1st Postmarket Safety Action: Study

Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not ...

motusgi
Read More
Positive Results for Roche Giredestrant in Some Breast Cancers

Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor...

Marketing

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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...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

Medical Devices

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FDA Clears Rx Digital Therapeutic for Adult ADHD

FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improv...

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FDA Neurological Regulator Joins Musk’s Neuralink

Reuters reports that Daniel McMullen, the former director of the CDRH Office of Neurological and Phy...

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Envoy Medical QS Violations

FDA warns Saint Paul, MN-based Envoy Medical about Quality System violations in its manufacturing of...

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Draeger Recalls Airway Catheter Mount

Draeger recalls (Class 1) its ErgoStar CM 60 (catheter mount 60), an airway connector/catheter mount...