Agency IQ

AUGUST 2, 2024

Rare Pediatric Disease Priority Review Voucher Program Expiration Threat: The FDA’s popular voucher program for rare pediatric diseases is currently scheduled to expire as of September 30, 2024 unless it is renewed by Congress.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JUNE 9, 2023

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. However, 95% of the over 6,000 recognized orphan diseases still have no treatment options.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Drug Hunter

APRIL 24, 2023

More older adults will also benefit from drug hunters’ previous pursuits to cure cancer, multiple sclerosis, and other serious diseases due to lower out of pocket maximums for Medicare beneficiaries. For perspective, 4.1

Small Molecule 130

Small Molecule Biosimilars Drugs Vaccine 130