As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below.
|Table 1—Fee Schedule for FY 2023|
|Generic drug fee category||Fees rates for FY 2023|
|Abbreviated New Drug Application (ANDA)||$240,582|
|Drug Master File (DMF)||78,293|
|Active Pharmaceutical Ingredient (API)-Domestic||37,544|
|Finished Dosage Form (FDF)-Domestic||213,134|
|Contract Manufacturing Organization (CMO)||51,152|
|Large size operation generic drug applicant||1,620,556|
|Medium size operation generic drug applicant||648,222|
|Small business operation generic drug applicant||162,056|
The Issue date of this notice is 12 October 2022.
Per the notice:
“Under sections 744B(a)(4) and (5) of the FD&C Act, respectively, facility and program fees are generally due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations act providing for the collection and obligation of GDUFA fees for the fiscal year. Here, that date is October 3, 2022. However, given the late date of the GDUFA reauthorization for FYs 2023 through 2027, facility and program fees for FY 2023 should be paid within 30 days from the issue date of this notice.”
Federal Register Vol 87, No. 194 announcing FDA 2023 PDUFA rates.
Due to a delay in the reauthorization of the Prescription Drug User Fee Act (PDUFA), the issuance of the annual fiscal year (FY) 2023 PDUFA program fee invoices was delayed. The Agency’s carryover funds are limited – as a result, FDA is requesting payment as soon as possible.
The fee rates for FY 2023 are displayed in table 15.
|Table 15.–Fee Schedule for FY 2023|
|Fee Category||Fee Rates for FY 2023|
|Requiring clinical data||$3,242,026|
|Not requiring clinical data||$1,621,013|
Federal Register Vol 87, No. 194 announces FDA 2023 MDUFA rates. See the Federal Register notice for details on the small business qualification.
|Table 5.–Medical Device Fees for FY 2023|
|Application Fee Type||Standard Fee
(as a percent of the standard fee for a premarket application)
|FY2023 Standard Fee||FY 2023 Small Business Fee|
|Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C 262))||Base fee specified in statute||$441.547||$110.387|
|Premarket report (submitted under section 515(c)(2) of the FD&C Act)||100%||$441,547||$110.387|
|Efficacy supplement (to an approved BLA under section 351 of the PHS Act)||100%||$441,547||$110.387|
|De novo classification request||30%||$132,464||$33.116|
|510(k) premarket notification submission||4.5%||$19,870||$4,967|
|513(g) request for classification information||1.35%||$5,961||$2,980|
|Annual Fee Type|
|Annual fee for periodic reporting on a class III device||3.50%||$15,454||$3,864|
|Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14)||Base fee specified in statute||$6,493||$6,493|
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business..
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.
Federal Register Vol 87, No. 194 Announces Biosimilar User Fee Rates for FY 2023
The fee rates for FY 2023 are displayed in table 7
|Table 7.–Fee Schedule for FY 2023|
|Fee Category||Fee Rates for FY 2023|
|Requiring clinical data||$1,746,745|
|Not requiring clinical data||$873,373|
For those that have not already submitted their CARES Act reporting for FY2020 and FY2021, do note per the regulation these reports are due. Although the FDA proposed dates for submission of these reports were non-binding, the reports themselves are indeed required. If you need assistance with the process, please contact EAS for support.
Reminder that the establishment registration and product listing renewal period began 1 October 2022. Kindly note the FDA has tightened up their validation process for listings. Although repack / relabeled listings have been submitted in the past without source NDC identification, this is no longer possible. Source NDCs must be included with all repack / relabel NDC listings. Also note, the FDA is now verifying business processes of all identified establishments in NDC listings. This could potentially slow down certification or updating of an NDC listing. Contact Victoria Pankovich, firstname.lastname@example.org if you would like EAS to handle your registration renewal and / or your NDC listing required updates or certification.
The FDA has updated 2 drug compliance programs effective 17 October 2022. Program 7346.832, New Drug Evaluation – Preapproval Inspections has the following revision: “Compliance program revised to add elements of International Council for Harmonisation (ICH) guidances for industry Q10 Pharmaceutical Quality System and Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,1 control of nitrosamine impurities, and alternative tools for evaluating facilities. Program 7356.002, Drug Quality Assurance – Drug Manufacturing Inspections has the following revision: “Revised to add elements of International Council for Harmonisation (ICH) guidances for industry Q9 Quality Risk Management, Q10 Pharmaceutical Quality System, and Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management;1 control of nitrosamine impurities; and alternative tools for evaluating facilities.”
Guidance Documents of Interest
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
This guidance explains how FDA will issue and use an information request and/or a discipline review letter during the assessment of an original abbreviated new drug application under section 505(j) of the Federal FD&C Act, as contemplated in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance does not apply to a supplement or an amendment to a supplement.
Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA
This guidance provides recommendations to industry on post-complete response letter teleconferences between FDA and abbreviated new drug application applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal FD&C Act. This guidance is intended to provide procedures that will promote well-managed post-CRL clarification teleconferences and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This guidance revises the guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA issued in December 2018.
ANDA Submissions – Prior Approval Supplements Under GDUFA
This guidance is intended to assist applicants preparing to submit to FDA prior approval supplements and amendments to PASs for abbreviated new drug applications under section 505(j) of the Federal FD&C Act. The guidance explains how the Generic Drug User Fee Amendments relates to PAS submissions. The guidance revises the guidance of the same title issued in October 2017. This revision is being issued to incorporate the performance goals currently outlined in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years that FDA has agreed to meet and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the performance goals in the GDUFA III commitment letter.
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
This final guidance is intended to assist original applicants and holders of approved new drug applications, abbreviated new drug applications, and biologics license applications with implementing a chemistry, manufacturing, and controls postapproval change through the use of a comparability protocol. A CP is a comprehensive, prospectively written plan for assessing the effect of a proposed postapproval CMC change(s) on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality).
Providing Over-the-Counter Monograph Submissions in Electronic Format
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance provides information on providing electronic submissions to FDA under the Federal FD&C Act.
This guidance provides a description of the process that applicants should follow to request designation of a drug as a Competitive Generic Therapy and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs. Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. This guidance revises the guidance of the same title issued in March 2020.
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing. This guidance revises the guidance of the same name issued in June 2015 to clarify that the largest dimension of a tablet should not exceed 22 mm and that capsules should not exceed a standard 00 size. This guidance also includes updated references.
Legacy Identification Number (NDC/NHRIC): Frequently Asked Questions
This page provides information about the use of National Drug Code (NDC) and National Health Related Item Code (NHRIC) created using labeler codes previously assigned to device manufacturers by the FDA (referred to here as “legacy FDA identification numbers”) on device labels and the enforcement policy related to these legacy identifiers, as set forth in the FDA’s May 2021 guidance, Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages.
UPC Alternatives UDI-A160001 and UDI-A160002: Frequently Asked Questions
Multiple Endpoints in Clinical Trials Guidance for Industry
This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well-recognized statistical methods for managing multiplicity within a study in order to control the chance of making erroneous conclusions about a drug’s effects. Basing a conclusion on an analysis where the risk of false conclusions has not been appropriately controlled can lead to false or misleading representations regarding a drug’s effects.
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs
This guidance is intended to assist applicants who are submitting abbreviated new drug applications for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called topical products. Because of the complex route of delivery associated with these products, which are typically locally acting, and the potential complexity of certain formulations, topical products (other than topical solutions) are classified as complex products.
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs
This guidance is intended to assist applicants who are submitting abbreviated new drug applications for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called topical products. Because of the complex route of delivery associated with these products, which are typically locally acting, and the potential complexity of certain formulations, topical products (other than topical solutions) are classified as complex products. This guidance provides recommendations for in vitro release test studies that can be used to compare a proposed generic (test) topical product and its reference standard for the purpose of supporting a demonstration of bioequivalence to the reference listed drug. The reference standard ordinarily is the RLD.
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs
This guidance is intended to assist applicants who are submitting abbreviated new drug applications for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are hereinafter called “topical products.” Because of the complex route of delivery associated with these products, which are typically locally acting, and the potential complexity of certain formulations, topical products (other than topical solutions) are classified as complex products. This guidance provides recommendations for in vitro permeation test studies comparing a proposed generic (test) topical product and its reference standard for the purpose of supporting a demonstration of bioequivalence to the reference listed drug. The reference standard ordinarily is the RLD.
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products of all potency groups hereinafter referred to as topical corticosteroids. This guidance describes recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids.
Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
This guidance proposes select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities. The existing guidance on the Breakthrough Devices Program remains in effect, in its current form, until this draft guidance is finalized.
Procedures for Handling Post-Approval Studies Imposed by PMA Order
A PAS is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device. The purpose of this guidance document is to assist stakeholders with understanding post approval study (PAS) requirements imposed as a condition of PMA approval. The final guidance “Procedures for Handling Post-Approval Studies Imposed by PMA Order” is intended to update and replace the guidance issued in June 2009.
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administration (FDA) with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device. The purpose of this guidance document is to assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) by providing information on how to fulfill section 522 obligations. The final guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” is intended to update and replace the guidance issued in May 2016.
All Guidance Documents can be searched on the FDA’s website.
FR Vol 87, No. 203 Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products
Joint Public Workshops – Medical Devices for Opioid Use
Date: November 7 – 8, 2022
Day1: Mon, Nov 7, 10:00 AM – 4:30 PM ET
Day2: Tue, Nov 8, 10:00 AM – 4:00 PM ET
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
Date: November 30, 2022
Time: 8:00 AM – 4:30 PM ET
FDA Clinical Investigator Training Course (CITC) 2022
Date: December 7 – 8, 2022
Day1: Wed, Dec 7, 11:00 AM – 3:35 PM ET
Day2: Thu, Dec 8, 10:55 AM – 2:40 PM ET
FDA Websites of Interest
Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types
Send and Track Medical Device Premarket Submissions Online: CDRH Portal
PDUFA VII: Assessment of FDA and Sponsor Communications Through Product Quality Information Requests
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
FDA Takes Steps to Further Harmonize Clinical Research Regulations with HHS Common Rule
FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing
Posted in Drug and Device Corner, Drugs, Medical Devices.