Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
4/26/2022
/ Consumer Product Safety Commission (CPSC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Opioid ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Purdue Pharma ,
Vaccinations
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the...more
On November 17, 2020, nine months after the start of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to Lucira Health for the first COVID-19 diagnostic test for...more
In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more
10/22/2020
/ Bayh-Dole Act ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Telehealth
Laboratory Developed Tests and Their Regulation -
Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more
Recently, the President issued an executive order (EO) for the purpose of ensuring that discounts offered on prescription drugs be passed down to patients. The subject matter of EO represents a key plank of a platform to 1)...more
This Client Advisory addresses some frequently asked questions for SARS-CoV-2 diagnostic test developers and provides an overview of recent updates relating to Emergency Use Authorizations (EUAs) published by the U.S. Food...more
Against a backdrop of an ongoing, disruptive COVID-19 pandemic; natural security concerns about disruptions in the availability of drugs, personal protective equipment, and diagnostic tests—and the widely variable quality of...more
On June 6, 2020, the U.S. Food and Drug Administration (FDA) issued a second revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National...more
On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued a revised Emergency Use Authorization (EUA) for disposable filtering facepiece respirators (FFRs) manufactured in China that do not meet National Institute...more
The number of cases of SARS-CoV-2 corona virus infection, and COVID-19, the disease caused by virus, continues to increase in the United States—both in number and in location (real-time map). At the same time, the number and...more
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), a $2 trillion stimulus package thought to be the largest in U.S. history. This is the third stimulus package adopted...more
On March 27, 2020, President Trump signed Public Law 116-136, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), the federal government's latest and most ambitious response to the COVID-19 crisis. As yet,...more
On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more
4/2/2020
/ 3D Printing ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs
In recent days, the U.S. Food and Drug Administration's (FDA's) policy granting authorization to manufacturers and laboratories for desperately-needed COVID-19 test kits has created mass confusion and even led to the...more
On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a new guidance on clinical trials of medical products during the COVID-19 pandemic, which provides general considerations to help sponsors assure the...more
The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more
The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number...more