jueves, 21 de julio de 2016

PDUFA Reauthorization/ Pediatric Clinical Investigator Workshop/ New Bacterial Vaginosis Guidance and ICH Guidance

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. Prescription Drug User Fee Act; Public Meeting; Request for Comments
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. The public meeting will be held on August 15, 2016, from 9 a.m. to 2 p.m. You may register for the meeting by August 8, 2016, at:http://pdufareauthorization.eventbrite.com.
2. Pediatric Clinical Investigator Training Workshop; Correction
FDA is correcting a notice that appeared in the Federal Register on June 16, 2016. The document contained an incorrect Web link for registration and an incorrect Web link for more information on the workshop. This document corrects those errors.
3. Bacterial Vaginosis: Developing Drugs for Treatment; Draft Guidance for Industry The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of bacterial vaginosis. 
4. E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report-Questions and Answers; International Council for Harmonisation; Guidances for Industry
The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

No hay comentarios: