US FDA User Fees
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New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.
Nearly 70% of the FDA workforce would be retained, most from carryover user fee dollars, but potential morale problems loom if government funding runs out again.
Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.
Six supplement categories based on submission content will be created with review goals between three and 10 months.
Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.
Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.
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