As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
2/6/2023
/ Biologics ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Legislative Agendas ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Safety Inspections ,
Supply Chain
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more
Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more
4/14/2020
/ CARES Act ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Creditors ,
Crisis Management ,
Exports ,
Federal Funding ,
Financial Solvency ,
Food and Drug Administration (FDA) ,
Government Assistance ,
Imports ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Recessions ,
Research and Development ,
Restructuring ,
Supply Chain ,
Vendors ,
Webinars
As part of its initiatives to expedite access to investigational drugs or biologics for the treatment of Coronavirus (COVID-19), on March 24, 2020, the US Food and Drug Administration announced that healthcare providers may...more
The Coronavirus (COVID-19) pandemic presents significant challenges for clinical trial sponsors. The US Food and Drug Administration issued guidance on March 19, 2020, that provides greater flexibility to adjust clinical...more
The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more
2/10/2017
/ 510(k) RTA ,
Biologics ,
Clinical Trials ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Laboratories ,
Medical Devices ,
Pharmacies ,
REMS ,
Software
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more