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Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS issued a final rule intended to govern the administrative dispute process in the 340B Drug Pricing Program. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On December 8, 2020, the Food & Drug Administration (FDA) issued guidance entitled,
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the ....

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