The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule...more
The Center for Devices and Radiological Health (CDRH), the section of the Food and Drug Administration (FDA) responsible for the regulation of medical devices, has issued a request for public comments on expanding patient...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
10/11/2022
/ 21st Century Cures Act ,
510(k) RTA ,
Biomedical Advanced Research and Development Authority (BARDA) ,
CDS ,
Coronavirus/COVID-19 ,
Dietary Guidelines ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
FDA De Novo Clearance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Proposed Rules ,
Public Health ,
Software ,
User Fees ,
Virus Testing
As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and...more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more
We recently published a post describing FDA’s recent actions to roll back enforcement policies implemented in response to the COVID-19 pandemic. On December 22, 2021, FDA took another step in that process by publishing...more
What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more
12/16/2020
/ Biologics ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Infectious Diseases ,
Laboratory Developed Tests ,
Life Sciences ,
Public Health ,
Virus Testing
Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more
10/29/2020
/ Biologics ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Investigational New Drug Application (IND) ,
Proposed Rules ,
Provider Relief Fund ,
Public Health Emergency ,
Vaccinations
After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more
Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the...more
The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
4/7/2020
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Emergency Use Authorization (EUA) ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Equipment ,
Medical Supplies ,
NIOSH ,
Personal Protective Equipment ,
Public Health ,
Public Health Emergency ,
Unique Device Identifiers
On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health...more
In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA)...more
As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the...more