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
On December 2, 2022, President Joseph Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (Cannabis Research Act), which provides a mechanism for industry and academia to access and research cannabis,...more
12/29/2022
/ Cannabidiol (CBD) oil ,
Cannabis Act ,
Cannabis Products ,
Controlled Substances Act ,
Doctor-Patient Privilege ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Joe Biden ,
Legislative Agendas ,
Marijuana ,
Medical Marijuana ,
Physicians ,
Research and Development ,
Schedule I Drugs ,
State and Local Government
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets...more
Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic.
The transactional and regulatory issues as...more
For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...more
3/16/2021
/ Administrative Procedure Act ,
Best Practices ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Life Sciences ,
Litigation Strategies ,
Negotiations ,
Physicians ,
Regulatory Violations ,
Risk Mitigation ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/14/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/13/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/7/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
HPE New York brings together preeminent healthcare private equity executives and investment bankers and unmatched keynote speakers to your remote workspace in a cutting-edge format – unlike any other conference this...more
10/6/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
The August 6, 2020, Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States directs the FDA and other federal agencies to take actions that could expand...more
On July 21, 2020, the US Food and Drug Administration (FDA) issued a long-awaited draft guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which...more