Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to...more
Introduction: Alpha-Gal Syndrome -
Alpha-gal syndrome (AGS) is an allergy to red meat and other products made from mammals. In addition to red meat allergy, AGS can also manifest as frequent and deadly-if-untreated...more
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
The Federal Circuit recently issued a split panel decision on induced infringement. The court's decision is important in that it may, if upheld upon further appeal and not distinguished by subsequent courts, limit the ability...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
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
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
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
Guidance Relevant for Purposes of Determining Orphan Drug Designation and Exclusivity. Finalizes Six Other Gene Therapies.
Two "hot" areas in drug development are i) gene therapies, and ii) therapies for orphan diseases....more
The legal definitions of a drug and a medical device set forth in the Food, Drug, and Cosmetic Act have some important overlapping provisions. Because of the overlapping provisions, theoretically the U.S. Food and Drug...more
12/20/2019
/ 510(k) RTA ,
FDA Approval ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Pre-Market Notification ,
Premarket Approval Applications ,
Prescription Drugs ,
Regulatory Burden ,
Statutory Interpretation ,
Venture Capital
The 21st Century Cures Act created the Regenerative Medicine Advanced Therapy (RMAT) designation in recognition of the growing importance of regenerative medical therapies. An RMAT designation conveys significant regulatory...more
Introduction: Citizen Petitions in the News -
Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more
11/7/2019
/ Abbreviated New Drug Application (ANDA) ,
Administrative Proceedings ,
Anti-Competitive ,
Biosimilars ,
Citizen Petitions ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Noerr-Pennington Doctrine ,
Public Health ,
Sham Citizen Petitions
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
/ Biotechnology ,
California Consumer Privacy Act (CCPA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Consumer Product Safety Commission (CPSC) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Technology-Assisted Review ,
Telemedicine ,
Value-Added Services
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more
A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more
2/7/2019
/ Amended Legislation ,
Amended Regulation ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Farm Bill ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Hemp ,
Marijuana ,
Marijuana Related Businesses ,
Patents ,
Utility Patents
Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more
High throughput sequencers, including next generation, or NGS, sequencers; polymerase chain reaction, or PCR, machines; flow cytometers; and other instruments are routinely used in conducting in vitro diagnostic assays. Many...more
The U.S. Food and Drug Administration (FDA) recently issued a dense, 24-page draft guidance, titled "Content of Premarket Submissions for Management of Cyber Security in Medical Devices" (the guidance). The guidance notes...more
A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more
Over the counter (OTC) drugs are medicines sold directly to consumers without a prescription from a healthcare professional. Traditionally, the range of OTC drugs has been limited to medical diseases and conditions for which...more