Advisory Committee for Pharmaceutical Science
S. Hussain, Ph.D.
Director, Office of Pharmaceutical Science, CDER, FDA
Meeting October 21 and 22, 2003
Dear ACPS Members and Invited Guests,
We look forward to meeting you on 21 & 22 October 2003 to discuss several
important scientific topics. On October
21 progress reports of the various subcommittees will be presented to you for
your assessment and recommendations. Following
these reports highlights of the draft PAT guidance (issued on September 3, 2003) presented along
with a progress report on the PAT Initiative. Rest of October 21, 2003 will be devoted to discussion
on the "Parametric Tolerance Interval for Dose Content Uniformity of
Aerosol Products." We had introduced this topic to ACPS as an awareness topic at the March 13, 2003 meeting. We have
continued to make progress on this, however the progress has been very slow and
we wish to seek your input on ways to accelerate progress. In addition to the
briefing information included along with this memorandum, information we
provided to you for the March 13th meeting is available at http://www.fda.gov/ohrms/dockets/ac/03/briefing/3926b2.htm.
On October 22,
2003 we have selected three topics for discussion. First topic is
the "Risk-Based CMC Review" first introduced to the ACPS at the
November 2000 meeting (see - http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3657b1a.htm).
At this meeting we plan to share with you new proposals on risk based CMC
review process within the context of Pharmaceutical cGMP's for the 21st
Century Initiative and Quality by Design. In addition to the document
describing our current thinking on the topic, two presentations at the recent
Manufacturing Subcommittee are provided as background information. This
discussion will be followed by a discussion on "drug product nomenclature"
and some of the challenges we are facing today.
Questions to the committee on this topic are attached. Final topic for discussion will be our
proposed strategy and plans for research to support the generic drug program.
Some of the challenges we face in assessing the therapeutic equivalence of
topical generic products was previous discussed at this meeting (e.g., November
200 meeting on topical skin products. Questions
to the committee on this topic are attached.
You may wish to review the discussion at the previous meetings (http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3661b1.htm).
We look forward to meeting you on October 21st 2003 and wish you a safe
journey to Rockville.