Days Until PDUFA Expires: 2 DAYS.
While PDUFA reauthorization is coming down to the wire, expectations are that the program will be reauthorized in the upcoming CR in the next few days. Fortunately, there are indications that the program will be reauthorized for five years.
Further positive signs: SBIR is also expected to be reauthorized for three years. BioNJ has engaged the State’s Congressional delegation with opportunities to learn about the program and to urge support for clean reauthorization. We are hopeful that this source of funding for the life sciences remains available.
As members of the World Trade Organization, including the U.S., contemplate a Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver for COVID-19 therapeutics and diagnostics expansion, BIO conveyed strong opposition on September 26, which you can see here.
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