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Food and Drug Administration (FDA) Regulation

Jones Day

FDA Issues Further Guidance Related to FSVP

Jones Day on

On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the Foreign Supplier Verification Program ("FSVP") regulation. The three-page...more

Foley & Lardner LLP

FDA's Plan to Regulate LDTs

Foley & Lardner LLP on

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

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