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Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Haug Partners LLP

Next-Generation Antibodies: Antibody-Drug Conjugates

Haug Partners LLP on

Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more

Mintz - Health Care Viewpoints

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

Mintz - Health Care Viewpoints on

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more

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