| Comment Record |
|
Commentor |
Ms. Jenny Peters |
Date/Time |
2002-01-28 14:22:23 |
|
Organization |
Global Regulatory Affairs; Pharmacia Corp |
|
Category |
Company |
| Comments for FDA General |
| Questions |
|
1. General Comments
|
(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We thank you for the opportunity to comment on this draft guidance.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;
|
|