Docket Management
Docket: 02D-0350 - Draft Guidance on Handling & Retention of Bioavailability & Bioequivalence Testing Samples
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Jenny Peters Date/Time 2002-09-20 11:08:20
Organization Pharmacia
Category Company

Comments for FDA General
Questions
1. General Comments Pharmacia appreciates the opportunity to review the “Draft Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples.” We applaud the efforts of the FDA to provide direction regarding this topic. Lines 363 through 368 – The text is needlessly prescriptive and burdensome. It will require companies who do conduct in-house BA/BE studies to purchase and maintain redundant equipment and storage areas--as well as the associated infrastructure. So long as appropriate access procedures are in place and detailed records are kept, it should not be necessary for the clinical study unit to maintain a separate storage facility. The specific titles of the staff may vary. Therefore, we recommend deletion of the following text: 1) from line 363 – “in the clinical study unit.” and 2) from lines 365/366 – “to the clinical investigator or research pharmacist.” For the same reasons, we don’t agree it is it is appropriate to note that 3rd party storage is recommended and advised (lines 349 and 367/368). Only one month was allowed comment instead of the more typical three months (the guidance appeared in the Federal Register on 21 August with comments due by 20 September). We question the abbreviated comment period. We thank you for the opportunity to comment on this draft guidance.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 269-833-8141




EC -1