AAPS Offers Workshop on Chemistry and Manufacturing Controls Regulatory Process

ARLINGTON, Va. - The American Association of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Streamlining the Chemistry and Manufacturing Controls (CMC) Regulatory Process for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), June 11-13, 2001 at the Hyatt Regency Washington on Capitol Hill in Washington, D.C.

This workshop, co-sponsored with the Food and Drug Administration (FDA), will review the FDA categorization of post-approval changes as major, moderate or minor as reflected in the November 1999 guidance on changes to an approved NDA or ANDA. Attendees will discuss the industry perspective using the guidance and identify parts of the guidance that may warrant revision.

Participants will discuss a new initiative, under investigation by FDA, which for specific drugs will reduce the CMC information and data to be included in original NDA/ANDA manufacturing supplements. Workshop attendees will also develop scientific, risk-based criteria that could be used to identify drug substances and products that would be eligible for the new initiative.

Scientists attending the workshop will help to develop a summary report that FDA will consider when revising the guidance on "Changes to an Approved NDA or ANDA" and developing the guidance for the new initiative.

Additional information on the AAPS Workshop on Streamlining the CMC Regulatory Process for NDAs and ANDAs can be found on AAPS Pharmaceutica at www.aapspharmaceutica.com/cmc.

About AAPS
AAPS is a professional, scientific society of more than 11,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. For more information about AAPS, visit AAPS Pharmaceutica at www.aapspharmaceutica.com.

* * *