http://www.businesswire.com/news/home/20151102005606/en/Osiris-Therapeutics-Announces-Addition-Wound-Care-Portfolio#.VjeKGS4tOWk.mailto
Yep, this is bad! http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM469751.pdf
Overblown. This is initial guidance, not regulations. it will be changed before the dust settles or in worst case the products will remain on the market while trials are conducted.