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FDA Adverse Event Reporting System (FAERS) Public DashboardDRUGS

Four FAERS summary statistics reports updated with data through December 31, 2013....

2018 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory CommitteeDRUGS

This page contains the meeting materials for the Peripheral and Central Nervous System Drugs Advisory Committee meetings for 2018, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentat...

2016 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory CommitteeDRUGS

This page contains the meeting materials for the Peripheral and Central Nervous Advisory Committee meetings for 2016, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, s...

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Electronic Submissions PresentationsDRUGS

List Electronic Submissions Presentations...

2017 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory CommitteeDRUGS

2017 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee...

Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book - 10/27/2020 - 10/28/2020DRUGS

Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book...

A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing ApplicationsDRUGS

To identify measures that might accelerate the development of generic drug products, CDER researchers recently investigated factors that might predict the likelihood that an abbreviated new drug application (ANDA), relying on a given reference (approved) drug product, would be su...

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