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Generic = Branded Drug, What are the Facts? Krebs Qin
July 03, 2024
It is no secret that the U.S. military does not trust the quality of generic drugs, and their disagreements and disagreements with the FDA over the quality control of generic drugs have long been made public.
FDA Publishes New Guidance on Protecting Participants in Bioequivalence Studies During COVID-19 americanpharmaceuticalreview
January 25, 2021
The U.S Food and Drug Administration (FDA) has published a new guidance for industry, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
US FDA publishes compliance policy for quantity of samples retained for BA and BE studies expresspharma
August 20, 2020
The US FDA has published the guidance for industry entitled “Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c).”
TissueCypher® Further Validated to Accurately Risk Stratify Barrett's Esophagus Patients With Non-Dysplastic or Low-Grade Dysplasia Diagnoses: Findings Shared at Two Major GI Conferences En-CPhI.CN
October 24, 2019
Cernostics, developer of AI-driven image analysis solutions for pathology assessment of tissue biopsies, announced upcoming presentations at the American College of Gastroenterology (ACG) and ...
Biological E, GVK BIO Enter R&D Partnership contractpharma
August 05, 2019
GVK will develop injectable products for BE.
Takeda and BE collaborate expressbpd
June 27, 2017
To develop low-cost vaccines for low and middle-income countries