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On June 20, 2024, the FDA issued a draft guidance, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the need for switching studies to demonstrate a biosimilar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On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more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 September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised...more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
On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021)....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
The U.S. Food and Drug Administration has provided guidance for health care professionals to use convalescent blood plasma from patients who have recovered from COVID-19 as a potential treatment for currently infected...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
During the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) expects that workforces will be reduced at the same time that the use of medical products will increase....more
The U.S. Food and Drug Administration (FDA) recently issued a dense, 24-page draft guidance, titled "Content of Premarket Submissions for Management of Cyber Security in Medical Devices" (the guidance). The guidance notes...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
The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more