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 | 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On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with…
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BakerHostetler | USA | 22 Mar 2023
FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues…
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…
BakerHostetler | USA | 3 Mar 2023
An independent external evaluation conducted by the Reagan-Udall Foundation contained 15 recommendations aimed at strengthening the…
BakerHostetler | USA | 9 Aug 2022
If you have been to any kind of spa, beauty supply store or health food store in the past four years, chances are you have seen, if not purchased, a…
BakerHostetler | USA | 9 Mar 2020
With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding…
BakerHostetler | USA | 31 Dec 2018
The FDA released a statement that certain programs would continue to run during the shutdown…
BakerHostetler | USA | 23 Oct 2018
Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities…
BakerHostetler | USA | 9 Mar 2017
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and…