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August 26, 2022

FDA/PHUSE Computational Science Symposium – 09/19/2022

On This Page Date: September 19 – 21, 2022 Day1: Mon, Sep 19 3:00 PM – 7:00 PM ET Day2: Tue, Sep 20 9:00 AM – […]
August 26, 2022

Q2(R2) Validation of Analytical Procedures

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline presents a discussion of elements for […]
August 26, 2022

Q14 Analytical Procedure Development

Docket Number: FDA-2022-D-1503 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline describes science and risk-based approaches for […]
August 26, 2022

M12 Drug Interaction Studies

Docket Number: FDA-2022-D-1527 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy This guideline provides recommendation to promote a consistent […]
August 26, 2022

E11A Pediatric Extrapolation

Docket Number: FDA-2022-D-1562 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guideline is to provide recommendations for, and promote […]
August 26, 2022

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers

Docket Number: FDA-2020-D-1791 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This question-and-answer (Q&A) document is intended to clarify key issues to facilitate […]
August 25, 2022

Study Data Standards Update for CBER: Your Guide to a Successful Submission – 10/05/2022

On This Page Date: October 5, 2022 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR CBER […]
August 25, 2022

Office of Generic Drugs | Offices and Divisions

Immediate Office (IO) Sally Choe, Ph.D., Director, Office of Generic Drugs (OGD) Kendra Stewart, R.Ph., Pharm.D., (Acting) Deputy Director of Operations Iilun C. Murphy, M.D., Deputy […]
August 25, 2022

FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement – 11/14/2022

On This Page Date: November 14 – 16, 2022 Day1: Mon, Nov 14 10:00 AM – 3:00 PM ET Day2: Tue, Nov 15 10:00 AM – […]
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