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Could Park Doctrine be Overturned?

Attorney Jennifer Thomas says the Supreme Court may hear a case that challenges the governments threat of jail terms against responsible corporate off...

FDA General

Trump Administration Considers Gulfo as FDA Head Candidate

The Trump Administration reportedly adds Fairleigh Dickinson University professor and executive director of the Lewis Center for Healthcare Innovation...

Federal Register

Trump Blocks FDA, Other Federal Register Notices

The Trump Administration temporarily blocks new FDA and other agencies Federal Register notices until they have been reviewed and cleared by a preside...

FDA General

Latest FDA Warning Letters

In its latest batch of Warning Letters, FDA cites Porton Biopharma and Walters Pharmacy.

Medical Devices

Stakeholders Disagree with Parts of GLP Proposal

Stakeholders cite several areas of concern and disagreement with an FDA proposed rule modernizing its good laboratory practice requirements.

Human Drugs

Petition Questions Intranasal Naloxone Efficacy

Mucodel Pharma says FDA should consider whether applications for intranasal naloxone adequately address a potential efficacy disparity between that ro...

Medical Devices

CDRH de novo Clearance of Wound Retraction Device

CDRH grants de novo clearance for Prescient Surgicals CleanCision Wound Retraction and Protection System for surgical wound edge protection, retractio...

FDA General

HHS Says No Orders from Trump on Communication Blackout

Despite reports that the Trump Administration has issued an communication blackout at federal agencies, including FDA, an HHS official tells FDA Webvi...

Medical Devices

Five Areas to Address in Cybersecurity: Webinar

CDRH associate director Suzanne Schwartz says several changes were made in finalizing a guidance on managing medical device cybersecurity in response ...

Human Drugs

FDA-483 Shows Violations at Indias Hetero Labs

FDA releases the FDA-483 from its inspection at Indias Hetero Labs.