| Comment Record|
Ms. Jenny Peters ||
2002-01-28 13:48:17 |
Global Regulatory Affairs; Pharmacia Corp |
| Comments for FDA General |
1. General Comments
28 January 2002
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We thank you for the opportunity to comment on this draft guidance.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.
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