FDA Law Blog

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months. The number of RIEs also stands in stark contrast to the number of RIEs – more than 100 – that the Bioresearch Monitoring (BiMo) Program has performed.

Manufacturing 105

Manufacturing Compliance Drugs Clinical Trials 105

Camargo

DECEMBER 22, 2021

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. Biowaiver Eligibility.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Camargo

NOVEMBER 11, 2020

The guidance clarifies the differences between an RLD and an RS for use during in vivo bioequivalence studies to support an ANDA and how the Agency determines the appropriate RS to designate in the Orange Book. Manager of Regulatory Compliance. Co-Authors: Jenny Fielder. Ken Phelps. President and Founder. Bill Stoltman, JD.

Development 242

Development Bioequivalency Generic Drugs Production 242