FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access.

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Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

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