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Disclosure Requirements › Compliance › Drug Pricing

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Hall Benefits Law

PBM Contracts Could Expose Plan Sponsors to Fiduciary Liability

Hall Benefits Law on

A plan sponsor’s fiduciary duty to be transparent in Pharmacy Benefit Manager contracts safeguards plan participants’ interests and mitigates the risk of litigation, regulatory penalties, and reputational harm, say Hall...more

Foley & Lardner LLP

Employer Checklist for New Health Plan Price Transparency Rules and CAA

Foley & Lardner LLP on

The effective date is fast approaching for certain provisions of the Consolidated Appropriations Act of 2021 (“CAA”) and related regulations, and the Transparency in Coverage Rule. You can access previous articles written...more

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