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
Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more
8/25/2020
/ Appeals ,
FDA Approval ,
Life Sciences ,
Marketing Exclusivity Periods ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reaffirmation ,
Treatment Method Patents
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
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
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
Life Beyond FDA Clearance or Approval: The Reimbursement Challenge -
To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more
1/11/2018
/ Corporate Financing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Initial Public Offering (IPO) ,
Life Sciences ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Reimbursements ,
Venture Capital
Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more