On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more
5/15/2023
/ Artificial Intelligence ,
Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Discussion Draft ,
Food and Drug Administration (FDA) ,
GAO ,
Life Sciences ,
Machine Learning ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Research and Development
On Dec. 11, the U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of the coronavirus disease 2019 (COVID-19). An EUA differs from an approval in that...more
Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more
11/20/2020
/ Biologics ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Fraud ,
Healthcare Fraud ,
Manufacturers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Virus Testing
As the response to COVID-19 consumes more and more healthcare, industry and regulatory resources, developments in the FDA and pharmacy space not relating to COVID-19 are limited. When other developments are available, the FDA...more
With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more
Food/Dietary Supplements -
FDA Released a Supplemental Draft Guidance for the Intentional Adulteration Rule Under the Food Safety Modernization Act – The Food & Drug Administration (FDA) announced the availability of a...more