Michael M. Gaba

Michael M. Gaba

Holland & Knight LLP

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FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

3/11/2014 - FDA FDASIA Medical Devices

Foreign Food Producers Play Catch-Up as FDA Issues Draft Regulations to Implement New Food Safety Standards

The U.S. Food and Drug Administration (FDA) is in the process of implementing sweeping new regulations governing the production of both domestic and imported food products. Many foreign food producers will be at a...more

7/22/2013 - Farms FDA Food Manufacturers Food Safety GMO New Regulations

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

12/27/2012 - Drug Compounding FDA Pharmacies

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