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Public Meeting on Supplements and Other Changes to an Approved Application
February 7, 2007, Rockville, MD
FDA held a public meeting to solicit comments on issues that FDA should consider when developing revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs.
- Federal Register Notice of Public Meeting [TXT] [PDF]
- Meeting agenda [PDF] (updated 2/8/2007)
- Meeting Memorandum, Helen Winkle [PDF] (2/8/2007)
- Presentations (2/8/2007)
- Transcript [PDF] (2/13/2007)
Date: February 7, 2007
Time: 8:30 a.m. - 3:30 p.m.
Location: The public meeting was held at the Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD.
For more information, contact:
David J. Cummings
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 21, rm. 3525
Rockville, MD 20993-0002
301-796-2400
email: David.Cummings@fda.hhs.gov
Presentations
- Opening Remarks: Helen Winkle [PDF]
- Center Perspective: Douglas Throckmorton [PDF]
- OPS Perspective: Jon E. Clark [PDF]
- OPS Review Staff Perspective: Vilayat Sayeed [PDF]
- OPS Review Staff Perspective: Eric Duffy [PDF]
- OC Perspective: Rick Friedman [PDF]
- Consumer: Janet Ritter [PDF]
- GPhA Perspective: Rich Stec [PDF]
- PhRMA Perspective: Leo Lucisano [PDF]
- CHPA Perspective: Fred Razzaghi [PDF]
- SST Corporation: Arthur Fabian [PDF]
- I. Q. Auditing: Calvin Koerner [PDF]
- Genentech Inc.: Earl S. Dye, Ph.D. [PDF]
DVDs of the meeting are available for a cost at FDALive.com.
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Date created: January 5, 2007, updated February 13, 2007 |
