Among other means, PBOA advocates for the CMO/CDMO sector through docket submissions to FDA draft guidance, as well as letters to Congressional committees and direct testimony at Congressional hearings. Below are links to PDFs of PBOA submissions.
- December 30, 2021 – CARES Act Reporting Amounts – FDA-2021-D-1031-0019.pdf
- July 30, 2019 – Opioid Packaging – FDA-2019-N-1845.pdf
- Feb. 11, 2019 – Compounding Outsourcing GMPs – FDA-2014-D-0779.pdf
- Jan. 25, 2019 – Drug Shortages – FDA-2018-N-3727.pdf
- Dec. 18, 2018 – Data Integrity and cGMP Compliance Q&A – FDA-2018-D-3984.pdf
- Dec. 14, 2018 – ICH Q12 – FDA-2018-D-1609.pdf
- Nov. 15, 2018 – DSCSA product identifiers – FDA-2018-D-3175.pdf
- May 5, 2018 – Opioids Packaging – E&C.pdf
- April 20, 2018 – OMUFA – HELP.pdf
- April 11, 2018 – Opioid Packaging – HELP.pdf
- March 27, 2018 – Quality Metrics – FDA-2015-D-2537.pdf
- Feb. 16, 2018 – Tableting Encapsulating – E&C.pdf
- Jan. 3, 2018 – DSCSA ID of suspect product OMB review – FDA-2014-D-0609.pdf
- Jan. 2, 2018 – NDC future formats – FDA-2018-N-2610.pdf
- Oct. 20, 2017 – DSCSA identifying trading partners – FDA-2017-D-1956.pdf
- Oct. 10, 2017 – CMC postapproval changes – FDA-2017-D-2802.pdf
- Sept. 13, 2017 – OMUFA – Congressional Testimony.pdf
- July 11, 2017 – FDARA & GDUFA II – E&C.pdf
- March 27, 2017 – Cross Industry Quality Metrics – FDA-2015-D-2537.pdf
- Dec. 22, 2016 – Quality Metrics extension – FDA-2015-D-2537.pdf
- Nov. 9, 2016 – DSCSA Product Identifier – FDA-2016-N-2673.pdf
- Sept. 26, 2016 – Quality Metrics Technical Guidance – FDA-2016-D-1594.pdf
- Sept. 26, 2016 – Cross-Industry Quality Metrics – FDA-2016-D-1594.pdf
- July 8, 2016 – OTC Monograph – FDA-2016-N-1092.pdf
- July 8, 2016 – OTC Monograph – FDA-2016-N-1092.pdf – PRESENTATION SLIDES
- June 10, 2016 – OMUFA presentation – FDA-2016-N-1092.pdf
- Nov. 25, 2015 – Quality Metrics – FDA-2015-D-2537.pdf
- Nov. 25, 2015 – Cross Industry Quality Metrics – FDA-2015-D-2537.pdf
- June 15, 2015 – GDUFA presentation – FDA-2012-N-0882.pdf
- June 15, 2015 – GDUFA – FDA-2012-N-0882.pdf
- March 6, 2015 – GDUFA – FDA-2014-N-1168.pdf
- Sept. 17, 2014 – GDUFA transcript 1 – FDA-2014-N-1168-0026.pdf
- Sept. 17, 2014 – GDUFA transcript 2 – FDA-2014-N-1168-0027.pdf
