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Regulatory Requirements › Food and Drug Administration (FDA) › Drug Approvals

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

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

King & Spalding on

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

Goodwin

FDA’s Push for “Radical Transparency”: Key Takeaways from the Agency’s Publication of Complete Response Letters

Goodwin on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more

Hogan Lovells

New FDA inspection program released for “streamlined approach” for combination product cGMP

Hogan Lovells on

On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led Combination Products.”...more

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