On April 15, 1997 there was a meeting of AMDM and FDA to discuss the Proposal for regulating cell culture media, serum, and reagents for various clinical ex vivo applications. FDA expressed four concerns:

1. Infectious disease concern due to presence of serum or animal origin ingredients in some of the products.

2. Must be GMP manufacturing process. Sterility assurance a critical issue.

3. Safety and effectiveness as measured by cytotoxicity.

4. Labeling claim critical. Limitations of products must be clear to end users.

At the close of this meeting it appeared approval of the proposal may occur shortly. Both groups were to propose draft language for labeling.

Apparently approval became caught up in the machinery of FDA. As of today there has been formal report on progress from FDA. A telephone conversation between AMDM's attorney, J.Kahan and FDA's S. Alpert on September 23, 1997 revealed that discussions between CDRH and CBER have been ongoing. There are apparently several issues holding up the approval.

1. Should the submission be a 510(k) or a Master File?

2. There has been a review by both Offices of Compliance on marketing and promotional issues.

3. More products than just cell culture products will most likely be included in the final proposal returned by FDA.

Additional feedback from FDA is said to be targeted for this month.