JD Supra

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

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 ...
JD Supra

New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the ...
Nasdaq

BioNxt Enters the Final Stretch Before Human Trials for Next-Generation MS Drug

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 ...
RAPS

India’s CDSCO Says Bioequivalence Testing Centers Require Approval

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The National Law Review

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

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