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On June 20, 2024, the FDA issued a draft guidance, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the need for switching studies to demonstrate a biosimilar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On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more
On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a...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
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more