In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada.
• In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
12/20/2019
/ Canada ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Imports ,
Manufacturers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Supply Chain ,
Trade Policy ,
Trump Administration
Recent FDA Recall Highlights & Developments -
• The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
4/11/2019
/ Centers for Disease Control and Prevention (CDC) ,
Distributors ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Recalls ,
Manufacturer Liability ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Product Recalls
November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality...more
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more
In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more