Neil ☆ India, 2019-07-25 20:18 (1730 d 15:12 ago) Posting: # 20440 Views: 2,234 |
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when Drugs@FDAdoes not have Rld label guidelines for a drug, which one should be referred? Its USFDA submission Edit: See this post #3 and follow the Forum’s Policy. [Helmut] |
Helmut ★★★ Vienna, Austria, 2019-07-26 12:42 (1729 d 22:48 ago) @ Neil Posting: # 20443 Views: 1,773 |
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Hi Neil, do you see Guidelines on top of the page? What about the overarching “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA”? If in doubt, initiate a Controlled Correspondence. Otherwise, you risk an R-t-R. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |