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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

Dot Compliance

SEPTEMBER 11, 2022

Prior to ISO 9001:2015, the standard for Quality Management Systems (QMS) was ISO 9001:2005. The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded. ISO 9001 with Dot Compliance.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

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.

US Department of Health and Human Services 52

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

Drug & Device Law

JANUARY 25, 2024

308 (2005), which comes up not infrequently in drug and device product liability cases. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Darue Eng’g & Mfg. ,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52