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Zdrowie i gospodarka · 25/11/2016

FDA Releases Revised Draft Guidance for Cyclobenzaprine Hydrochloride Bioequivalence Studies

The Food and Drug Administration has released a revised draft guidance for the pharmaceutical industry on the bioequivalence of generic cyclobenzaprine hydrochloride extended release capsules, providing specific recommendations for supporting abbreviated new drug applications.

Source: Federal Register — Food and Drug AdministrationOpen original release →