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While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.
Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)
fit in this definition. January 2024 Amendments to Patent Term Restoration (Proposed Rule) FDA is proposing to amend its Patent Term Restoration regulations to identify the effective date of approval for scheduled drugs, to define when the 60-day period referred to in 35 U.S.C.
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