FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes

Author:

Wang Yan,Qin Bin,Xia Grace,Choi Stephanie H.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference27 articles.

1. In vitro-in vivo correlations of ocular implants (U01). 2013 [7/22/20]; Available from: https://grants.nih.gov/grants/guide/rfa-files/rfa-fd-13-029.html.

2. Wang Y, Qu W. Choi S. American Pharmaceutical Review: FDA’s regulatory science program for generic PLA/PLGA-based drug products; 2016.

3. CDER/FDA. Product-specific guidances for generic drug development 2020 [7/22]; Available from: https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm.

4. CDER/FDA Draft guidance on Risperidone injectable intramuscular 2020 [7/27]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risperidone_intramuscular%20injection_RLD%2021346_RV08-16%20separate%20post.pdf.

5. CDER/FDA. Upcoming product-specific guidances for complex generic drug product development (2020) [8/26]; Available from: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development.

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