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Pdufa Calendar 2023. The first half of 2022 is projected to be laden with opportunities for new drug approvals through the us. Portrait) on one page in easy to print pdf format. Blank pdf calendars were created with wincalendar and are free for download!
Fsma Compliance Dates | Fda from www.fda.gov
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Fsma Compliance Dates | Fda
The pdufa date refers to the date the food and drug administration (fda) are expected to deliver their decision whether or not a approve a companies new drug application (nda) or biologics license application (bla). Applicants are assessed a program fee for a fiscal year. An applicant will not be assessed more than five program fees for a fiscal year for prescription drug products identified in a single approved nda or bla (see section 736(a)(2)(c) of the fd&c act). 15 was extended by three months to allow time for review of additional information submitted by the company on estimated glomerular filtration rate, upon fda's request.
