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FDA Authority on BA/BE Testing Circulars by Maizee Keen is a document available to read on EtoBox.

What is FDA Authority on BA/BE Testing Circulars about?

The Supreme Court ruled that the FDA has the authority to issue Circular Nos. 1 and 8, s. 1997 to administer and supervise the implementation of AO 67, s. 1989, which originally introduced the bioequivalence testing requirement for certain drugs. While Circular Nos. 1 and 8 are not considered administrative regulations themselves, they help implement an existing primary legislation without affecting substantive rights, so no prior notice or hearings were needed. The Court found AO 67 to be a validly issued

Author

Maizee Keen

Language

EN