Approvable letter
id:
approvable-letter-0-5824198
title:
Approvable letter
text:
Approvable letters, and the related non-approvable letters, were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314
brand slug:
wiki
category slug:
encyclopedia
description:
original url:
https://en.wikipedia.org/wiki/Approvable_letter
date created:
date modified:
2023-09-05T05:50:58Z
main entity:
{"identifier":"Q60745998","url":"https://www.wikidata.org/entity/Q60745998"}
image:
fields total:
13
integrity:
13