Matthew Piscitelli

Foley Hoag LLP

+ Follow Contact

Latest Posts › New Guidance

Share:

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

8/11/2025 / Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Manufacturers , National Security , New Guidance , Pharmaceutical Industry , Public Health , Regulatory Reform , Supply Chain

FDA’s Major Statement: The Agency’s Recent Direct-to-Consumer CCN Final Rule, Q&A Guidance and Enforcement Trends

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more

1/3/2024 / Advertising , Direct to Consumer Sales , Enforcement Actions , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , New Guidance , Prescription Drugs

OMB Releases Artificial Intelligence Memorandum to Federal Agencies

Following the landmark October 30, 2023 executive order on artificial intelligence (AI), the White House Office of Management and Budget (OMB) issued a draft memorandum to federal agency heads for the use of AI within their...more

11/22/2023 / Artificial Intelligence , Biden Administration , Executive Orders , Government Agencies , Machine Learning , New Guidance , New Legislation , OMB , Regulatory Reform , Regulatory Requirements

3 Results

View per page

Page: of 1