This article provides a summary of the draft guidance[1] released by the FDA to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to the FDA. The draft guidance was released on October

This is a cross-posted blog from The Blunt Truth.

Despite the dearth of approved marijuana products, the term “medical marijuana” has become commonplace, and the term’s prevalence continues to increase as more states legalize the use of the marijuana plant and its active derivatives for medical purposes, and marijuana dispensaries continue to expand throughout the United States. As of 2017, 29 states and the District of Columbia have approved the use of marijuana for medical purposes. (Despite state laws legalizing marijuana for medical and/or recreational use, marijuana remains a Schedule I controlled substance its distribution and use remain illegal under Federal law.)
Continue Reading Is Medical Marijuana Really Medicinal?

This article summarizes information taken from the following sources:  FDA’s Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013) & information set forth in the following link: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm

In order to launch a generic version of an approved reference listed drug (“RLD”), an applicant must file an abbreviated new drug application (“ANDA”) generally demonstrating, among other things, that a proposed generic drug product is bioequivalent (“BE”) to the RLD.[1]
Continue Reading FDA Provides New Product Specific Guidance for Development of Certain Generic Drug Products

shutterstock_96589270The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) amended Section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)) in providing ways to obtain licenses for certain biological products via abbreviated applications from the Food and Drug Administration (“FDA”) in order to market biosimilar products or interchangeable products for therapeutic uses.