News Focus
News Focus
icon url

justdafactss

08/14/21 6:14 PM

#179046 RE: Ambersavage7194 #179032

What woman and wheres the link?

But to answer your question---

When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and given the investigational drug; patients already in the study are expected to be taken off therapy involving the investigational drug unless treatment continuation is specifically permitted by FDA in the interest of patient safety.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold#:~:text=IND%20Application%20Procedures%3A%20Clinical%20Hold%20A%20clinical%20hold,IND%20application%20may%20be%20placed%20on%20clinical%20hold.