Tag: life sciences regulatory & compliance

Significant 340B Drug Pricing Program Litigation May Impact 340B Scope - Life Sciences Perspectives Significant 340B Drug Pricing Program Litigation ...

In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that ...

Newly Launched: Goodwin’s Laboratory Developed Tests Resource Page - Life Sciences Perspectives Newly Launched: Goodwin’s Laboratory Developed Tests Resource Page ...

On October 23, 2023, FDA announced the availability of a revised draft guidance titled “Communications From Firms to Health Care ...

The U.S. Food and Drug Administration (FDA) has announced an upcoming webinar on its proposed rule on the regulation of ...

After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight ...

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory ...

Summary: On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 ...

On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule ...

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its ...