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.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 9, 2023

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA 40

FDA Science Biosimilars Production 40

Drug Hunter

APRIL 24, 2023

The act reduces the patient out of pocket cost maximum for Medicare Part D drugs to $2,000 which will improve affordability of high cost drugs and enable more patients to access these treatments developed by drug discovery scientists.

Small Molecule 130

Small Molecule Biosimilars Drugs Vaccine 130