United States: Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List) - Hyman, Phelps, & McNamara, P.C.

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27 Oct 2023 0 shares 1 views

United States: Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List) - Hyman, Phelps, & McNamara, P.C.

Mondaq

Published 27 Oct 2023

This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the "single study plus confirmatory evidence" pathway...

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United States: FDA Brings Its Formal Meetings Guidance Up To Date: What You Need To Know About Type D, INTERACT, And "In-Person" Meetings Under PDUFA - Hyman, Phelps, & McNamara, P.C.

Much has changed since the long-gone days of 2017. The Washington Nationals won the World Series, Presidential administrations have..

Mondaq 27 Oct 2023

United States: Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List) - Hyman, Phelps, & McNamara, P.C.

United States: Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List) - Hyman, Phelps, & McNamara, P.C.

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United States: FDA Brings Its Formal Meetings Guidance Up To Date: What You Need To Know About Type D, INTERACT, And "In-Person" Meetings Under PDUFA - Hyman, Phelps, & McNamara, P.C.

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