Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more
7/23/2024
/ Chevron Deference ,
Decision-Making Process ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
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
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On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
10/25/2023
/ Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Labeling ,
Medical Devices ,
Medical Software ,
Pharmaceutical Industry ,
Policies and Procedures ,
Regulatory Requirements ,
Regulatory Standards