US FDA User Fees
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
BsUFA III Meeting Improvements To Cut Requests, Improve Biosimilar Development Efficiency
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.
GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors
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.
GDUFA III Agreement Will Constrain Fee Revenue Increases
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing
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.
Bright Spot With Potential Shutdown: More FDA Staff Would Continue Working
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.
US FDA Aims To Speed Communications On Cell And Gene Therapy Issues With Q&A Guidance
Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
Real-World Evidence Under Consideration For Use In Interchangeable Biosimilars Applications
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.
BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals
Six supplement categories based on submission content will be created with review goals between three and 10 months.
A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created
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.
Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
US FDA’s Stein ‘Excited’ About Real-World Evidence, Rare Disease Endpoint Pilot Programs
Head of Office of New Drugs highlights programs being established under PDUFA VII that could help overcome obstacles in drug development.
PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.