Blog Post
07/31/2017
By Jonathan A. Havens

On July 28, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a new, comprehensive plan for tobacco and nicotine regulation that will place nicotine, and the issue of addiction, at the center of the Agency’s tobacco regulatory efforts.

Blog Post
07/21/2017
By Jonathan A. Havens

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), Ranking Member Frank Pallone (D-NJ), and Health Subcommittee Ranking Member Rep. Gene Green (D-TX), the Act would reauthorize four key U.S.

Blog Post
07/19/2017
By Jonathan A. Havens

The U.S. Food and Drug Administration’s (FDA or the Agency) decision a couple of months ago to delay its Menu Labeling Rule until May 7, 2018, as discussed here, was met with mixed reactions from industry.

Blog Post
06/21/2017
By Jonathan A. Havens

On June 15, 2017, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is developing a new Digital Health Innovation Plan (the Plan), through which FDA hopes to encourage industry growth by providing more regulatory certainty to device developers. Gottlieb also indicated that the Agency will soon pilot a new, risk-based approach toward regulating digital health technologies.

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