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# Stakeholders Suggest Regulatory Science Topics
- URL: https://www.fdaweb.com/stakeholders-suggest-regulatory-science-topics/
- Published: 2018-06-27T12:00:00.000Z
- Updated: 2026-09-15T00:16:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141779

Generic drug stakeholders have recommended regulatory science research topics for FDA to pursue in Fiscal Year 2019\. The Association for Accessible Medicines [suggests](https://www.regulations.gov/document?D=FDA-2017-N-6644-0006&ref=fdaweb.com): orally inhaled products, in-vitro methods, biowaivers, global reference product, CQAs, human factors considerations for sameness, identifying in-vitro alternatives to clinical endpoint studies, assessment of suitability of existing in vitro bioequivalence tests, combination drug device products, and drug product formulation.

The National Institute for Pharmaceutical Technology and Education [calls](https://www.regulations.gov/document?D=FDA-2017-N-6644-0004&ref=fdaweb.com) on FDA to consider ways to improve awareness of the need for attention on adequate education, training, and experience for all aspects of generic drug development and regulatory approval process. It gives some specific recommendations for the agency to consider.

Perrigo [responds](https://www.regulations.gov/document?D=FDA-2017-N-6644-0008&ref=fdaweb.com) to questions posed at a 5/24 FDA public workshop. The comments relate to **(1)** the effect on generic drug formulation of business-related decisions that involve Q1/Q2 or not and **(2)** the degree of device sameness and performance for complex combination products.

Finally, Teva [says](https://www.regulations.gov/document?D=FDA-2017-N-6644-0005https://www.regulations.gov/document?D=FDA-2017-N-6644-0005&ref=fdaweb.com) it believes FDA and industry “can better utilize existing technologies and regulatory pathways to further streamline generic drug development. It calls on the agency to: 

- review and update, where appropriate and backed by scientific research, all guidances that call for clinical endpoint studies to ensure they recommend the most efficient and relevant techniques and methodologies;
- leverage data already available to reduce to reduce *in vivo* requirements; and
- ensure that recommendations based on academic research are realistic and accessible to industry.