draft guidance
FDA Issues Guidance for Promotional Material
A new draft guidance by the FDA focuses on promotional materials and use of data that are off-label.
JANUARY 24, 2017
FDA Issues Draft Guidance on Biosimilars Interchange
The FDA released its draft guidance recommending how sponsors of proposed therapeutic proteins can demonstrate ...
JANUARY 20, 2017
FDA Abuse-Deterrent Opioid Draft Guidance for Generics: A Missed Opportunity?
In an effort to guarantee that generic versions of abuse-deterrent formulation (ADF) opioids are as safe and ...
MAY 11, 2016
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