Search Results for keywords:"biological products"

The Food and Drug Administration (FDA) has released a draft guidance titled "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices." This document aims to help sponsors, clinical investigators, and institutional review boards define, identify, and report protocol deviations effectively during clinical investigations. It offers definitions and a classification system for reporting these deviations, allowing consistent documentation and interpretation. Comments on the draft can be submitted electronically or in writing by February 28, 2025, to help shape the final guidance.

The Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUAs) for biological products during the COVID-19 pandemic, one requested by Pfizer, Inc., and the other by ModernaTX, Inc. These Authorizations allow the use of vaccines to help manage the public health emergency declared by the Secretary of Health and Human Services. The Authorizations include specific conditions and are part of efforts to protect public health and national security in response to the SARS-CoV-2 virus, which causes COVID-19. The FDA ensures that such products can be used when there are no adequate, approved alternatives available.

The Food and Drug Administration (FDA) is organizing a public workshop called "Optimizing Pregnancy Registries" on March 27-28, 2025, both in-person at the FDA White Oak Campus in Silver Spring, MD, and online. The aim of the workshop is to address the challenges in designing pregnancy registries and discuss innovative approaches to enhance their effectiveness in assessing the safety of drugs and biological products during pregnancy. The event is in collaboration with the University of Maryland's Center of Excellence in Regulatory Science and Innovation program. Participants from academia, industry, healthcare, and patient communities will explore strategies to improve these registries.