tips for a successful nda submission
Published 8 years ago • 3.9K plays • Length 55:41Download video MP4
Download video MP3
Similar videos
-
59:56
worried about your next fda meeting? key tips to make it a success
-
1:00:47
understanding new drug applications (ndas)
-
23:35
division of filing review: helpful tips for submission of an anda or controlled correspondence
-
49:32
keys to success for your integrated summary of safety (iss) and integrated summary of efficacy (ise)
-
5:36
nda or anda submission
-
57:19
bench to clinic: preparing for a successful transition
-
55:29
the 505(b)(2) nda pathway - an innovative fda strategy that everyone should understand webinar
-
39:07
best practices for 505(b)(2) and anda applicants
-
1:10:48
cmc - nda requirements and common pitfalls of blas (14of15) redi – may 29-30, 2019
-
30:32
abbreviated new drug application
-
2:51
regulatory submissions and applications
-
5:50
para four filing procedure, and 180 days exclusivity
-
18:12
writing for regulatory submissions and drug protection activities (ind, nda, bla, snda, anda)
-
56:44
taking full advantage of the nda pathway webinar
-
7:24
preparing a study using the self-check worksheet: nda clinical study
-
38:21
nda and bla application review process (6of15) redi annual conference – may 29-30, 2019
-
8:31
fda 505(b)(2) applications seminar part iv: the thin line between a 505(j) and 505(b)(2)
-
41:15
understanding the new fda guidance on data standards
-
27:10
overview of post-approval chemistry, manufacture, and controls (cmc) changes to an nda - redi 2020
-
59:03
improve the inclusion & exclusion criteria for your next clinical trial
-
49:15
webinar replay: tips for successful prcrp applications
-
1:01
510(k) tip - when should you submit a pre-sub?