Laura Macherelli

BakerHostetler

+ Follow Contact

Latest Posts › Federal Food Drug and Cosmetic Act (FFDCA)

Share:

FDA Authorizes Marketing of Zyn Nicotine Pouches

The U.S. Food and Drug Administration (FDA) recently approved the marketing of 20 Zyn nicotine pouches, marking the first time nicotine pouches have received such authorization. This decision came through the premarket...more

1/31/2025 / Consumer Protection Laws , FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Marketing Authorization Application , Public Health , Tobacco

FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more

5/2/2024 / Clinical Laboratories , Compliance , Diagnostic Tests , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices

Cybersecurity in Medical Devices

The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more

4/10/2023 / Cybersecurity , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance

3 Results

View per page

Page: of 1