4 ms·
Just to give some context. It’s not directly my line of work, but my employer filled out a New Drug Application (NDA) with the FDA recently and we were told the
by anotherboffin 5y ago
Just to give some context. It’s not directly my line of work, but my employer filled out a New Drug Application (NDA) with the FDA recently and we were told the whole thing exceeds 200’000 pages. Given the size and amount of data in there, one year seems reasonable for FDA review.