Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases. -FDA

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

SQA

AUGUST 8, 2023

The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. cosmetic regulatory framework.

FDA 40

FDA Compliance COVID-19 World Health 40