505(b)(2) NDAs
Website https://www.complianceonline.com/505b2-new-drug-applications-webinar-training-705930-prdw?channel=ou |
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Deadline: February 27, 2019 | Date: February 27, 2019
Venue/Country: U.S.A
Updated: 2019-01-25 15:45:12 (GMT+9)
Call For Papers - CFP
NDAs submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD & C) are a those for which the product is not a generic nor a traditional brand. It allow sponsors to reference data that was not generated by them. This type of submission can shave years off of the development process and save millons of dollars. Attend this webinar to learn which products qualify for submissions under 505(b)(2), data that may be referenced, content requirements, and regulatory benefits.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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