· By Sanofi Admin

Drug Development 101: FDA Responses to New Drug Applications

Authored by: Don Gieseker, Associate Vice President Regulatory Affairs
In the Drug Development 101 series here on Speaking of Sanofi, we have explored topics related to the FDA review process for new drugs, including the types of applications that can be submitted to the FDA and the meaning of a PDUFA date. Today, we shed some […]

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 · By Sanofi Admin

Drug Development 101: What’s in a (Drug) Name?

Judy_Plon

This post was authored by Judy Plon, Associate Vice President, Regulatory Affairs, US Consumer Healthcare at Sanofi US
Have you ever heard a drug name and wondered about the story behind it? Developing the name and getting it approved is actually a very complex process. Today, we’re shedding some light on what it involves, as part […]

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 · By Sanofi Admin

Drug Development 101: Applying for FDA Approval of Medications

FDA

This post was authored by Barry Sickels, Vice President, Regulatory Affairs at Sanofi US
The first two posts in our Drug Development 101 series provided insight into important elements of the drug development and approval process – Advisory Committee Meetings and the Prescription Drug User Fee Act (PDUFA). Both typically come into play after a drug […]

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 · By Sanofi Admin

The Next Big Thing: The Future of Biosimilars in the US

This post was authored by Cary Yonce, Vice President, General Therapeutics and Life-Cycle Management at Sanofi US.
In the third and final edition of the National Press Foundation’s (NPF) educational webinar series, NPF President Sandy K. Johnson sat down with Michael Kleinrock, director of research development for IMS Institute for Healthcare Informatics and Dr. Jeremy Greene […]

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