News
Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
Publications
News
How to navigate gene editing regulatory hurdles: FDA webinar clarifies newly finalized guidance
14 March 2024
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...
News
Beyond Earth's Gravity
31 January 2024
In the Space and Satellite arena, technology is ever-evolving, expanding, and combining in ways never before contemplated. These innovations bring many legal, regulatory, and contractual...
Insights and Analysis
Beyond Earth’s Gravity: Navigating legal hurdles in space-based drug research and development
30 January 2024
In the Space and Satellite arena, technology is ever-evolving, expanding, and combining in ways never before contemplated. These innovations bring many legal, regulatory, and contractual...
News
FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s
07 December 2023
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing...
News
Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases
12 October 2023
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program...
News
Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases
11 October 2023
On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program...
News
After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies
28 March 2023
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will...
News
O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision
19 January 2023
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should...
