Episode 335 -- The New DOJ Whistleblower Program
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
Understanding the Whistleblower Pilot Program in the Southern District of New York
On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics Evaluation and Research (“CBER”)...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase...more
In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope of the FDA’s oversight...more
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more
In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more