Food and Drug Administration
The ASRS is a leading advocate and trusted voice to the U.S. Food and Dug Administration (FDA) on key regulatory issues that affect physician choice of prescription and compounded drugs, including the ability to provide prompt in-office medical treatment to patients and access to Avastin.
The Society provides retina-specific perspectives and guidance to the Agency in an effort to shape policy that will enable timely access to the most appropriate drug for the patient to ensure consistent delivery of high quality care.
ASRS keeps its members abreast of important policy developments while also working with other stakeholders to advise and educate the FDA as it develops critical policies on topics including:
- Compounding: Patient-Specific Requirements on 503As
- Guidance on Biologics: Restrictions on Beyond-Use Dates
- United States Pharmacopeia (USP)
FDA Comment Letters
ASRS Again Urges USP to Stick with Science for Establishing BUDs -- December 2018
- ASRS Comments: Regulations Governing Drug Compounding -- June 2017
- ASRS Letter re: Revised Draft Guidance on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application -- March 2017
- ASRS Comments on Prescription and Hospitals and Health System Compounding Requirements Under FDA Draft Guidance --July 2016
- ASRS Comments on FDA Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application -- May 2015