User Fees

The STAR pilot established in PDUFA VII for efficacy supplements, which was modeled after the popular Real Time Oncology Review program, has not garnered much interest. The agency now is establishing a separate but similar pilot for a small number of original NDAs and BLAs.

The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.

Inflation accounted for a larger portion of user fee revenue target increases for fiscal year 2025, compared to previous years, according to a Pink Sheet analysis.

FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.

“It's really the elected officials who are making the final determination on what happens. They're really the owners of the teams, you guys in the industry are playing the game we’re refereeing,” FDA Commissioner Robert Califf says at Consumer Healthcare Products Association conference.

Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”