Reference no: EM133199271

1. What is true regarding the regulation of biologics? MORE THAN ONE ANSWER

a. Biologics are mostly regulated by CBER

b. Biologics that are regulated by CBER have their own designated inspectorate

c. In order to gain an understanding of how well a company is performing when the FDA is not around, biologic PLIs/PAIs are performed as surprise inspections.

d. The 600s require specific time and temperature requirements for sterilization

2. 7. What is true regarding the autologous stem cell clinics? MORE THAN ONE ANSWER

a. Most of the 700+ stem cell clinics are operating without GMP controls in place

b. Stem cells are minimally manipulated and thus don't pose much of a threat at all - to date no one has been harmed by these treatments

c. The Federal Courts have handed down two somewhat conflicting rulings on FDA's regulation of the stem cell clinics - in one case, FDA's injunction was granted and in another, it was not

d. There is plenty of clinical trial data to support the type of autologous stem cell therapy administered by these clinics