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Earlier this week, the Food and Drug Administration released the latest in a series of draft guidance documents on the topic of real-world data (RWD) to support regulatory decision-making for drugs...
We know that the Circuit Court of Cole County, Missouri has ruled against covid mandates recently. Yesterday the judgement (PDF) was issued. THE PRESIDENT OF USA HAS LOST. And given the arguments here, the President is certain to lose the trial as well. Defendants are preliminarily enjoined from the implementation and enforcement of 86 Fed.…
After two years of consideration, the FDA has restricted the sale of breast implants to healthcare providers that use an FDA-approved patient-decision checklist to discuss the benefits...
Key Takeaways - The COVID-19 pandemic led the U.S. Food and Drug Administration (FDA) to pause most foreign and domestic inspections and begin conducting remote interactive...
To embed, copy and paste the code into your website or blog: On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and Cosmetics Act (FDCA). The Ensuring Innovation Act exchanges the term “active ingredient” with the term “active moiety” in sections of the FDCA governing NCE and ODE. The five-year NCE exclusivity provision contained in the FDCA states in part: If an application submitted under subsection (b) for a drug, no ...