Advocacy

AAPS Advocacy

AAPS experts comment on high-impact scientific guidances from regulatory agencies around the world.

If you’d like to join us in providing pharmaceutical science expertise, please contact us:

Stacey May, Director of Public Outreach
MayS@aaps.org
703.248.4740 

World Health Organization (WHO)

DISSOLUTION TEST FOR SOLID ORAL DOSAGE FORMS
Proposal for revision for The International Pharmacopoeia
View Guidance (PDF)

View Comments (PDF)

Research America

Sign-on letter thanking ranking members of the House and Senate Subcommittees on Labor, Health and Human Services for securing robust funding increases for medical and public health research.

View Letter (PDF)

Food and Drug Administration (FDA)

Statistical Approaches to Evaluate Analytical Similarity: Draft Guidance for Industry 


View Guidance (PDF)

View Comments (PDF)

European Medicines Agency (EMA) 

Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development 

View EMA Guidance (PDF)

View Comments (PDF)

British Pharmacopoeia (BP)

Consultation Dissolution testing in BP finished products monographs for solid oral dosage forms


View BP Guidance web page

View Comments(coming soon)