BakerHostetler | USA | 9 Jan 2024
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.
BakerHostetler | USA | 3 Nov 2023
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved…
BakerHostetler | USA | 23 Oct 2023
FDA’s Commitment to Regulate Digital Health Technologies: The U.S. Food and Drug Administration (FDA) is establishing a Digital Health…
BakerHostetler | USA | 22 Aug 2023
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health…
BakerHostetler | USA | 15 Aug 2023
On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with…
BakerHostetler | USA | 28 Jun 2023
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for…
BakerHostetler | USA | 15 May 2023
On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the…
BakerHostetler | USA | 10 Apr 2023
The FDA has issued new guidance to the medical device industry highlighting the critical need for manufacturers to address cybersecurity…
BakerHostetler | USA | 16 Mar 2023
The FDA has issued a Federal Register notice explaining how the end of the COVID-19 Public Health Emergency (PHE) declaration will…
BakerHostetler | USA | 15 Mar 2023
The FDA has launched a new "Dietary Supplement Ingredient Directory" that allows users to search for information on ingredients in…