News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Investigational New Drug Application (IND)

Alston & Bird

Health Care Week In Review: CMS Releases Guidance on Medicare Prescription Payment Plan and House Holds a Hearing on 19 Health...

Alston & Bird on

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,...more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more

Seyfarth Shaw LLP

FDA Provides Guidance on How to Request Authorization to Use Convalescent Plasma as a Treatment for COVID-19

Seyfarth Shaw LLP on

Convalescent blood plasma from patients who have recovered from COVID-19 is a potential treatment that has gained scientific interest. Because COVID-19 convalescent plasma has not yet been approved by FDA, it is regulated as...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2015

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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