Introduction: Meat Alternatives and Cultured Meat -
Conventional meat production has been implicated in environmental damage, the rise of antibiotic resistant bacteria, and increasing emission of greenhouse gasses....more
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) regarding speaker programs hosted by pharmaceutical and medical device companies. Speaker programs are company-sponsored...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
Recently, the U.S. Food and Drug Administration (FDA) issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the "intended use" of a product. Intended use is important...more
Food Associated Disease Outbreaks -
Food safety in the United States is something that most consumers take for granted. However, there are instances where illness, usually attributed to bacterial infections, can be traced...more
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
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
Recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to Luminex Corporation. Luminex "manufactures microsphere-based and [polymerase chain reaction] PCR-based multiplexing systems for in-vitro...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
COVID-19, the disease caused by the SARS-CoV-19 virus, is complex, and the number, type, and severity of symptoms often vary from patient-to-patient. COVID-19 complications and outcomes can vary by age, the presence of...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
Drugs can be divided into two categories: 1) Prescription (Rx) drugs, which require a physician's or other authorized healthcare provider's prescription to obtain; and 2) over-the-counter (OTC) drugs, which can be purchased...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
On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more
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
U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more
3/9/2020
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs
Pharmacogenetics, although in its infancy, has the potential to help predict how individual patients will respond to a given drug. Pharmacogenetics (or pharmacogenomics) is the study of "how genes affect a person's response...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
2/12/2020
/ CGMP ,
Consent Decrees ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Compounding ,
Due Diligence ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Patent Infringement ,
Product Recalls
The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more
2/3/2020
/ 510(k) RTA ,
Artificial Intelligence ,
Deregulation ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Medical Devices ,
Premarket Approval Applications ,
Public Workshops ,
Regulatory Burden ,
Regulatory Reform ,
Software