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Article

FDA Requesting Comments On Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration ("FDA") issued draft guidance (the "510(k) Transfer Guidance") related to the transfer of a Premarket Notification (510(k)) Clearance.

United States Healthcare

Katten Muchin Rosenman LLP

Article

FDA Targets Gene Editing Clinical Trials In China And Other "Hostile Countries"

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and "immediate review" of new clinical trials where American patients' cells are sent to China or other "hostile countries" for genetic engineering with the expectation that the cells will be infused back into U.S. patients

United States Healthcare

Crowell & Moring LLP

Article

FDA Issues Final Guidance Addressing Remote Regulatory Assessments

On June 26, 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a final guidance that describes the Agency's conduct and use of remote regulatory assessments (RRAs).

United States Healthcare

Arnold & Porter

Article

Virtual And Digital Health Digest

Worldwide Healthcare

Arnold & Porter

Article

Ohio Board Of Pharmacy Prescribes New Rules For Ohio Pharmacies

United States Healthcare

Buchanan Ingersoll & Rooney PC

Article

BioNTech Announces Transaction To Acquire CureVac

United States Healthcare

Goodwin Procter LLP

Article

Supreme Court Narrows Medicaid Beneficiaries' Right To Sue: Key Takeaways From Medina v. Planned Parenthood South Atlantic

United States Healthcare

Foley Hoag LLP

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Eurofast

Article

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