Ophthalmic Drug Discovery and Development: Regulatory Aspects of Patient Focused Drug Development in Ophthalmology

Author:

Rowe-Rendleman Cheryl L.ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference68 articles.

1. H.R.6 - 21st Century Cures Act 2015. Available from: https://www.congress.gov/bill/114th-congress/house-bill/6%20on%201 . Accessed on: 10/31/2018.

2. US Food and Drug Administration. Patient-focused drug development: Disease area meetings held in fiscal years 2013–2017. Available from: https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm347317.htm . Accessed on: 1/7/2019.

3. US Food and Drug Administration. Patient-focused drug development: Collecting comprehensive and representative input: Guidance for industry, Food and Drug Administration Staff, and other stakeholders. 2018. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM610442.pdf . Accessed on: 10/31/2018.

4. Methods to identify what is important to patients and select, develop, or modify fit-for-purpose clinical outcomes assessments. FDA, Department of Health and Human Services. Workshop October 15–16, 2018. Available from: https://www.fda.gov/downloads/Drugs/NewsEvents/UCM620707.pdf . Accessed on: 10/31/2018.

5. Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, et al. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res. 2000;9(8):887–900.

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