This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
1/17/2025
/ Artificial Intelligence ,
Compliance ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management
UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this....more
Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
11/14/2023
/ Antitrust Division ,
Competition ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more
7/3/2023
/ Agricultural Marketing Act ,
APHIS ,
Biotechnology ,
EU ,
Food and Drug Administration (FDA) ,
Genetically Engineered Seed ,
Life Sciences ,
Medical Foods ,
Pharmaceutical Industry ,
Plant Based Products ,
USDA
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will...more
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with...more
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more
3/31/2021
/ Biden Administration ,
CARES Act ,
Collaboration ,
Coronavirus/COVID-19 ,
Defense Contracts ,
Defense Production Act ,
Department of Justice (DOJ) ,
EU ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Life Sciences ,
Merck ,
Pharmaceutical Industry ,
Popular ,
Private Sector ,
Public Health Emergency ,
Supply Chain ,
Trump Administration ,
Vaccinations ,
World Health Organization