Bioequivalence and Bioavailability Forum • History Lesson: FDA NDA Submission back in the 50s

jag009
★★★

NJ,
2013-03-19 21:42
(4845 d 14:36 ago)

Posting: # 10239
Views: 2,853

History Lesson: FDA NDA Submission back in the 50s [Regulatives / Guidelines]

Hi,

Can someone give me a history lesson on NDA submission to the FDA back in the 1950s? How was it compared to now? I've read about the introduction of DESCI in 1968(of evaluating drugs that had not yet undergone clinical trials and review).

I am looking at an NDA submitted back in the 1950s and I only see limited clinical and tox data (forget PK, there was none). The clinical data doesn't even represent what a NDA submission requires these days. The NDA was for a anti-parasitic agent.

Thanks
John

drgunasakaran1
★★

2013-03-20 08:35
(4845 d 03:43 ago)

@ jag009
Posting: # 10240
Views: 2,229

History Lesson: FDA NDA Submission back in the 50s

Post reply

Dear Mr Jag009,

❝ Can someone give me a history lesson on NDA submission to the FDA back in the 1950s?

Between 1938 to 1940, around 2752 NDA applications were submitted to FDA. Out of 2752 NDA applications, FDA gave approval for 1782 NDA applications.

For Summary of NDA Approvals & Receipts, 1938 to the present with FDA, See here

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn