miércoles, 20 de diciembre de 2017

Susceptibility Test Interpretive Criteria/ Refuse to File Guidance/ Patient Focused Drug Development/ Opioid Policy Steering Committee

1. 21st Century Cures Act: Establishment of the Susceptibility Test Interpretive Criteria Website
FDA’s new Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act). Visit the website at: www.fda.gov/STIC
2. Refuse to File: NDA and BLA Submissions to CDER: Guidance for Industry
The purpose of this guidance is to clarify circumstances under which CDER may refuse to file a new drug application (NDA) or supplemental NDA (21 CFR 314.101(d)) or a biologics license application (BLA) or supplemental BLA (21 CFR 601.2) for a therapeutic biological product regulated by CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse-to-file (RTF) action by the FDA. 
3. Public Workshop on Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
On March 19th 2018, FDA is conducting a public workshop to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the FDA may submit such proposed draft guidance to the Agency. Additional information is located on the Meeting Webpage.
4. FDA's Opioid Policy Steering Committee - Prescribing Information - Exploring a Strategy for Implementation
The purpose of this public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics. The public hearing will be held on January 30, 2018 in Silver Spring, MD. Additional information is located on the Meeting Webpage

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