Drug Approvals and Launches from a Legal Perspective

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Torrey Cope, partner, food, drug, and medical device practice, Sidley Austin LLP, reveals current regulatory challenges in the U.S. for drug approvals, how a one-sized-fits-all approach to marketing and global launches no longer works, and when a global launch may be advantageous.

Launching a drug and receiving approvals—whether it’s in the U.S. or globally—is challenging to navigate. It’s a process that often takes years and a lot of back-and-forth communication with regulatory bodies.

In this episode, Torrey Cope, partner, food, drug, and medical device practice, Sidley Austin LLP, discusses drug approvals and drug launches from a legal perspective, including:

  • His work as an attorney
  • Tips for drug approvals from a legal perspective
  • Current regulatory challenges the industry is facing in the U.S.
  • The shift away from a one-sized-fitsall approach to marketing and global launches 
  • Tips for companies navigating the regulatory landscape in the U.S.
  • When to launch a drug in a country outside of the U.S.
  • Drug pricing

Join Meg Rivers, managing editor, as she dives into this topic with Cope.


About the speaker

Torrey Cope is a partner in Sidley’s food, drug, and medical device practice group. An experienced regulatory lawyer with scientific training, he has a passion for helping pharmaceutical, biotechnology, and medical technology companies solve their most challenging regulatory problems, whether they involve clinical trials, marketing authorization, promotion, product safety, or other issues. Many of his clients are working at the forefront of life sciences innovation in fields such as immunotherapy, regenerative medicine, genetic testing/next-generation sequencing, digital health, and artificial intelligence/machine learning.

About the PharmExec Podcast

The editors of Pharmaceutical Executive bring you the latest commercial insights to master the science of success. Podcast episodes examine current trends, key conferences, and critical topics in the bio/pharmaceutical industry.

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