Agency IQ

OCTOBER 6, 2023

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.

FDA 52

FDA Biosimilars Science Production 52

Agency IQ

FEBRUARY 12, 2024

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 (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

DECEMBER 1, 2023

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.

FDA 40

FDA Science Regulations Production 40