The U.S. Food & Drug Administration (FDA) recently announced draft guidance for industry on the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect. Guidance recommendations “are intended to assist developers in generating the data necessary to support …
FDA Draft Guidance on Development of Local Anesthetics with Prolonged Effect Read more »
The U.S. Food & Drug Administration recently announced an emergency use authorization (EUA) for the Lucira COVID-19 & Flu Home Test – the “first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known …
FDA Authorizes OTC At-Home Test to Detect Influenza & COVID-19 Viruses Read more »
The U.S. Food and Drug Administration (FDA) recently proposed “a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.” The draft recommendations are based on FDA’s review of …
FDA Proposed Change to Assessment of Blood Donor Eligibility Read more »
The CSU|LAW Library Center for Health Law & Policy Guide provides information on, and links to, scores of resources concerning general health law, bioethics, Medicare/Medicaid law, and public health law. The Guide covers key Federal and Ohio legislation and regulations, …
The United States District Court for the District of Maryland, Northern Division, recently ruled that the National Institutes of Health (NIH) violated the Chimpanzee Health, Improvement, Maintenance, and Protection (CHIMP) Act for not retiring former research chimpanzees to a sanctuary. …
Federal Court Rules NIH in Violation of CHIMP Act Read more »
