On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more
9/10/2020
/ Administrative Procedure Act ,
APIs ,
Department of Health and Human Services (HHS) ,
Essential Drug List ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Personal Protective Equipment ,
Prescription Drugs ,
Public Health Emergency ,
Stafford Act ,
Supply Chain ,
Trade Agreements
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
/ 510(k) RTA ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs
As the coronavirus outbreak continues to wreak havoc on markets and industries in the U.S. and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges...more
During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more
3/30/2017
/ Budget Cuts ,
Drug Approvals ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Health & Safety Standard ,
Life Sciences ,
Medical Devices ,
Medical Research ,
OMB ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration ,
User Fees
Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more
In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more