The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more
U.S. President Biden signed a bill last Thursday postponing the sunset date of the rare pediatric disease Priority Review Voucher (PRV) program from September 30, 2024, to December 20, 2024. The bill, the “Continuing...more
The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food and Drug Administration (FDA) in finding...more
On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When...more
The U.S. Food and Drug Administration (FDA) recently announced the establishment of a public docket to obtain information and comments to help FDA assess how best to advance the development of new biosimilar biological...more
The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial deference to administrative...more
7/15/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products...more
On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug...more
With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly “improperly listed” patents in the Food and Drug...more
4/8/2024
/ Competition ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Hatch-Waxman ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 5
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of critical factors. FDA officials...more
The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food and Drug Administration's (FDA)...more
Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more
The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we summarized online here. In the article below, we...more
The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that would come into play upon...more