Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in health care 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:
On Wednesday, HHS finalized its review of Phase 3 Provider Relief Fund applications and began distribution of the funds. Read more about this action and other news below.
I. Regulations, Notices & Guidance
On December 14, 2020, the Department of Health and Human Services (HHS), along with several other agencies, issued a final rule entitled,
Equal Participation of Faith-Based Organizations in the Federal Agencies’ Programs and Activities. This rule provides clarity about the rights and obligations of faith-based organizations participating in the Agencies’ Federal financial assistance programs and activities. This rulemaking is intended to ensure that the Agencies’ Fed
Center for Drug Evaluation and Research
This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence.
This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Generic Drug Development. The September 2015 guidance was issued as part of FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA I). This guidance is being issued to incorporate program enhancements related to the review of controlled correspondence to which FDA committed, and industry agreed, as part of the reauthorization of GDUFA (GDUFA II).