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On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more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 May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more
To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020. ...more
On November 17, 2015, the FDA finalized a guidance document, that was first issued as a draft in March 2013, regarding formal meetings between the FDA and biosimilars applicants. Because meetings with biosimilars applicants...more
The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an...more