FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
7/31/2020
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Notice of Proposed Rulemaking (NOPR) ,
Prescription Drugs ,
Public Safety ,
State Implementation Plans (SIPs) ,
Trump Administration ,
Waivers
Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more
11/19/2019
/ Biologics ,
Chief Compliance Officers ,
Compliance ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Diagnostic Tests ,
Export Controls ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Risk Assessment ,
Risk Management ,
Supply Chain
Since its enactment in 2003, Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) has been a dead letter in the law. The provision authorizes the importation of certain prescription drugs from Canada, but only if...more