| Comment Record |
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Commentor |
Ms. Jenny Peters |
Date/Time |
2002-01-28 13:48:17 |
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Organization |
Global Regulatory Affairs; Pharmacia Corp |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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28 January 2002
Dear Sir/Madam:
Further to our comments sent earlier via Airborne (dated 24 January 2002), please note the following:
1. Lines 145-147: When both test product and RLD are rapidly dissolving, have similar dissolution profiles, and contain a drug substance with high solubility and high permeability (BCS Class I), as defined in the BCS guidance....
Comment - Should add: except where the RLD has food specific labeling.
2. Lines 152-153: When the label of the RLD does not make any statements about the effect of food on absorption or administration....
Comment - Should add: for BCS Class I drugs.
As with our earlier submission, the line designations refer to the guidance document located at the Internet site: http://www.fda.gov/OHRMS/DOCKETS/98fr/010488g1.pdf. We noticed that there is another numbering of the guidance at http://www.fda.gov/cder/guidance/4613dft.PDF.
We thank you for the opportunity to comment on this draft guidance. Please let us know if you have any questions on our review.
Sincerely,
Jenny Peters
Director
Global Regulatory Affairs
Global Regulatory Policy & Intelligence
Mail Stop 0636-298-112
Pharmacia Corporation
7000 Portage Road
Kalamazoo, Michigan 49001
telephone: (616) 833-8141
facsimile: (616) 833-0512
jenny.l.peters@pharmacia.com
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