Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...
The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition ...
Following successful small-animal trials that confirmed bioequivalence, BioNxt is now taking the final preclinical step to prepare its sublingual Cladribine formulation for human testing. The upcoming ...
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