TAG ARCHIVES FOR codify 21 CFR 59 subpart D

25
Oct2022

On September 25, the US Food and Drug Administration (FDA) released a draft guidance, “Ethical Considerations for Clinical Investigations for Medical Products Involving Children.” The draft guidance is intended to help industry, sponsors, and IRBs when considering enrolling children in clinical investigations of drugs, biological products, and medical devices. Public comments are being accepted until December 27, 2022.  Read more