A Significant Departure: Unpacking What the New Antitrust Guidelines Mean for Healthcare Providers
Medical Device Legal News with Sam Bernstein: Episode 8
Paycheck Protection Program – Common Questions and Updated Guidance
Scrutiny Increasing On Energy Private Equity Valuation
#WorkforceWednesday: Look Beyond OSHA, Accommodation Clarification, Workshare Programs - Employment Law This Week®
Employment Law Now IV-70 - Understanding the Latest EEOC Covid-19 Guidance
Episode 89 -- DOJ Issues New Guidance on Evaluation of Corporate Compliance Programs
On June 20, 2024, the FDA issued a draft guidance, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the need for switching studies to demonstrate a biosimilar is...more
On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more
A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more