Agreement with FDA/DOJ

After nine years of a very public difference of opinion, the FDA, the Department of Justice and AniCell Biotech have reached an agreement regarding AniCell’s amnion products and their regulatory designation. As per the Consent Decree below, AniCell has agreed to engage an independent regulatory expert to evaluate AniCell’s products and determine whether each is a “medical device” or a “drug”. It is AniCell’s position that its amnion products are medical devices – consistent with their human analogs – and we are confident that the independent expert will reach that conclusion as well.

Please stay tuned as this plays out over next few months. It’s business as usual here at AniCell, and as always we remain committed to setting the industry standards for amnion products and serving veterinarians and the animals they care for. We are also grateful to have reached a hard earned agreement with the government, and look forward to a productive relationship for years to come. Click the link below to register or visit our website at www.anicellbiotech.com/events.

Contact us to find out how AniCell products are extending the ACTIVE life of animals.