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Food and Drug Administration (FDA) › Administrative Procedure

Goodwin

Charting a Conditional Approval Pathway for Rare Disease Drugs - A Top Priority for a Revamped FDA?

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On April 18, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. ...more

Holland & Knight LLP

CMS Proposes Transitional Coverage for Emerging Technologies

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more

Goodwin

USPTO Doubles Down Calling Out Pharmaceutical Industry

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​​​​​​​The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties of disclosure and reasonable inquiry during examination of a patent application,...more

Ervin Cohen & Jessup LLP

FDA Issues Final Rule for Lab Accreditation for Food Testing

Ervin Cohen & Jessup LLP on

On December 1, 2021, the U.S. Food and Drug Administration (“FDA”) issued a final rule establishing the Laboratory Accreditation for Analyses of Food (“LAAF”) program. FDA will utilize the LAAF program to recognize...more

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