The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling...more
The U.S. Food and Drug Administration (FDA) has finalized its 2018 draft guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,” which offers...more
Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
Recently, the U.S. Food and Drug Administration (FDA) released two proposed rules that aim to clarify inconsistencies between FDA’s human subject protection regulations and the Federal Policy for the Protection of Human...more
Last week, the U.S. Food and Drug Administration (FDA) published the final guidance, “Pre-Launch Activities Importation Requests (PLAIR),” describing its policy regarding requests for the importation of unapproved finished...more
The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more
There are two parallel sanctions processes unfolding in Washington, D.C. – one from the Biden administration and the other from the U.S. Congress. Regardless of what approach the government takes, we do not expect the life...more
A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more
On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO) waiver of intellectual property (IP) rights...more
5/12/2021
/ Biden Administration ,
Coronavirus/COVID-19 ,
Infectious Diseases ,
Intellectual Property Protection ,
Life Sciences ,
Patent Ownership ,
Pharmaceutical Industry ,
Popular ,
TRIPS Agreement ,
Vaccinations ,
WTO
Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more
3/26/2021
/ Clinical Trials ,
Drug Design ,
Educational Institutions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Research and Development ,
Universities
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more
1/26/2021
/ Advertising ,
Electronic Communications ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Misbranding ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Promotional Items ,
Warning Letters
In Tuesday's Report: FDA warns over drug misbranded as COVID-19 treatment; podcast discusses Trump's "Buy American" executive order; an op-ed on the importance of protecting biomedical innovation; HHS sees high level...more
10/26/2020
/ Biopharmaceutical ,
Buy America ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Life Sciences ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Trump Administration
Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more
10/26/2020
/ Coronavirus/COVID-19 ,
Enforcement Actions ,
False Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Misbranding ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Safety Standards ,
Warning Letters
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
...more
9/29/2020
/ CDRH ,
Centers for Disease Control and Prevention (CDC) ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Reform ,
Trump Administration ,
Virus Testing
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more
In Tuesday's Report: Germany clarifies restrictions on dispensing in-vitro diagnostic kits, UK partners with Valneva on vaccine production, U.S. CDC reverts to older guidance, HHS bars health agencies from signing new rules,...more
On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for Over-the-Counter (OTC) drugs. ...more
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and Hydroxychloroquine Sulfate — to treat COVID-19. ...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more
7/23/2019
/ Biotechnology ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Imports ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Standards ,
Rulemaking Process ,
Secretary of HHS ,
Supply Chain ,
Working Groups
FDA authority to crack down on illegally marketed stem cell treatments confirmed -
On 3 June a U.S. District Court in Florida issued a decisive blow against US Stem Cell Clinic LLC, granting the U.S. Food and Drug...more