FDA Law Blog

JUNE 10, 2024

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance.

Compliance 111

Compliance Bioequivalency Cosmetics Regulation 111

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

XTalks

FEBRUARY 8, 2021

Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. This replaces the previous approval pathway for insulin drugs and their analogs which have historically been reviewed as new drug applications under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Production 78

Production Insulin Branding Generic Drugs 78

FDA Law Blog

JANUARY 23, 2023

Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act). This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol.

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59