beeldscherm schreef op 15 november 2017 08:58:
A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.[3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
ik kom tot 74 dgn....Wie??
dus eindsept begin okt aanvraag... plus 74 dgn eind dec 2017..