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Biologics/Biosimilars Webinar Series: FDA/Regulatory Overview

Jan
28
2016

Date: January 28, 2016

Time: 3:00PM

Location: Webinar

Topics

  • FDA/Regulatory Overview

Event Details

In this second installment of our biologics/biosimilars series, we'll touch upon FDA and regulatory aspects facing researchers, manufacturers, and distributors of biologic-based therapeutics.  We will discuss approval pathways, give an overview of the BPCIA, and discuss post-BPCIA BsUFA, exclusivities, and naming.

Speakers

Professional Cropped Bentley Linda Mintz

Linda D. Bentley

Panelist

Linda D. Bentley has extensive knowledge of the FDA and other agencies that regulate the Pharmaceutical, Biotechnology, and MedTech, Tools, and Devices fields. At Mintz, she uses her knowledge of technology, regulatory requirements, clinical trials, and health care to advise clients.
Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.