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
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
Executive Summary -
On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...more
11/10/2023
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Vaccinations
On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document entitled, “Good Machine Learning Practice for...more
10/29/2021
/ Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Canada ,
Healthcare ,
International Medical Device Regulators Forum (IMDRF) ,
Machine Learning ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
Regulatory Oversight ,
Technology Sector
On June 30, 2020, the U.S. Food and Drug Administration (FDA) released new guidance to provide recommendations for sponsors to facilitate development of SARS-CoV-2 vaccines to prevent COVID-19. The guidance highlights key...more