2029, Biosimilars and Documentation

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2029

Biosimilars

Documentation

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time.

Documentation

Documentation Drug Development

California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

JULY 15, 2022

In a budget change proposed in February and confirmed in May , California’s Department of Health Care Access and Information (HCAI) requested a one-time investment of $100 million for Newsom’s CalRx Biosimilar Insulin initiative. The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin.

Pharmacist Digest

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

California’s low-cost insulin plans receive $100m manufacturing boost

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