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FDA Finalizes PDUFA User Fee Guidance
September 27, 2011By Michelle L. Butler –
On September 27th, FDA published a guidance document regarding user fee waivers, reductions, and refunds for drug and biological products. See 76 Fed. Reg. 59705 (Sept. 27, 2011); FDA, Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (Sept. 2011). This is a final version of the document FDA published in draft in March 2011, which we described in detail here.
According to the Federal Register notice that announced publication of the guidance document, the Agency received no comments in response to its request for comments on the draft guidance document earlier this year, and the only changes to the guidance document were minor editorial changes and a small clarification. This clarification pertains to the determination of whether an applicant has limited financial resources for purposes of the public health and barrier to innovation waiver grounds. FDA clarified that $20 million benchmark for determining that an applicant has limited resources for user fee purposes will begin with fees assessed for FY 2011. Guidance, at 8. For waivers of fees for fiscal years prior to 2011, “the Agency intends to continue to use as its general market of limited resources the $10 million benchmark cited in the 1993 interim guidance, adjusted for inflation.” Id. at 8, n.20.
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- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized