The FDA has announced FY2020 User fees, please scroll down for further information.
EAS recently sent an email update regarding FDA’s intention to begin inactivating drug listing records, effective 13 Sept 2019. The FDA has found that tens of thousands of drug listing records contain errors. The agency announced their intentions in the Federal Register on 14 August 2019. The main concern with these non-compliant listings is their lack of certification as being active and up-to-date, or the listings are associated with a drug establishment no longer duly registered with the FDA. The notification also points out that some companies have simply opted to not renew registrations / certify listings and have considered this sufficient notification to the FDA. However, this practice is not compliant with the regulations. To appropriately close files, a de-registration SPL file must be submitted to the FDA for an establishment registration and a ‘Marketing Complete’ file (which includes the expiration date of the last batch of product introduced into U.S. commerce) must be submitted for a drug listing.
If the FDA does inactivate a listing, the listing record will note this and it will be removed from all public drug listing databases maintained by FDA. This includes the NDC Directory and the NDC SPL Data Elements (NSDE) file. Any such drug that is still marketed will be deemed misbranded and the company involved will be subject to FDA enforcement action. This would be particularly problematic for foreign companies when importing products into the U.S.
The agency also notes in their announcement that manufacturers and repackagers of products subject to the new product identification requirement, must submit the updated labeling to their product listings. This update will satisfy the annual certification requirement and therefore such products will not need the “blanket no changes” submission to maintain the listings’ active status.
While on the topic, labeler codes should also be current and reflect accurate contact information for the labeler. If you have any questions or concerns regarding your company’s status, EAS is here to assist.
A message was communicated recently from the FDA re approved (A)NADA labeling. By 30 September 2023 the following statements (as applicable) must be included on approved (A)NADA labeling: Approved by FDA under NADA# xxx-xxx OR Approved by FDA under ANADA# xxx-xxx. This requirement applies to all approved animal drugs currently on the market. If you need further information on this topic, please contact EAS.
The FDA, in their ongoing effort to update the IID Database, has announced their most recent changes. Information about FDA’s plans for upcoming changes to the IID can be found on the IID web page. The web page will be continually updated as FDA makes changes to the IID over the coming year.
The FDA has published the following user fee rates for their FY2020, which runs from 1 Oct 2019 – 30 Sept 2020:
- Generic Drug User Fee Rates for Fiscal Year 2020
- Medical Device User Fee Rates for Fiscal Year 2020
- Prescription Drug User Fee Rates for Fiscal Year 2020
- Outsourcing Facility Fee Rates for Fiscal Year 2020
- Biosimilar User Fee Rates for Fiscal Year 2020
- Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2020
- Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2020
Annual Establishment facility fee rates effective 1 October 2019 are as follows:
- Medical Device: $5,236
- Domestic API facility: $44,400
- Foreign API facility: $59,400
- Domestic FDF facility: $195,662
- Foreign FDF facility: $210,662
- Domestic CMO facility: $65,221
- Foreign CMO facility: $80,221
Guidance Document updates on the FDA website:
- Pathology Peer Review in Nonclinical Toxicology Studies: Q & A This guidance provides information to sponsors and nonclinical laboratory staff regarding the management and conduct of pathology peer review performed during good laboratory practice (GLP)-compliant toxicology studies.
- Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment The purpose of this guidance is to provide recommendations to industry for designing nonclinical bone quality studies to support the approval of drugs and biologics intended for the treatment of osteoporosis.
- Gastroparesis: Clinical Evaluation of Drugs for Treatment This guidance addresses FDA’s current recommendations regarding clinical trial designs and clinical endpoint assessments to support developing gastroparesis drugs for treating idiopathic and diabetic gastroparesis.
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate nonclinical program for the development of radiopharmaceuticals to treat cancer — also known as oncology therapeutic radiopharmaceuticals — and to provide recommendations for certain aspects of product labeling.
- E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES This document focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.
- Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment This guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of uUTIs.
- Vulvovaginal Candidiasis: Developing Drugs for Treatment The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for treating vulvovaginal candidiasis (VVC).
CDER & CBER
- Male Breast Cancer: Developing Drugs for Treatment This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer.
- Child-Resistant Packaging Statements in Drug Product Labeling The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.
- Fabry Disease: Developing Drugs for Treatment The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that can support approval of drugs and biological products intended for the treatment of Fabry disease (FD).
- Bacterial Vaginosis: Developing Drugs for Treatment The purpose of this guidance is to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for the treatment of bacterial vaginosis (BV).
- General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products This draft guidance is intended to assist sponsors of new drug applications (NDAs), biologics license applications (BLAs), and supplements who are planning to conduct clinical studies in neonatal populations.
- Rare Pediatric Disease Priority Review Vouchers This guidance provides information on the implementation of section 908 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which added section 529 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Under section 529, FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section.
- Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention This guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of prevention of DGF.
- Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment This draft guidance document provides Food and Drug Administration’s recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.
- Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions This guidance document provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems.
- CVM GFI #257 (VICH GL57) The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements for drugs intended for using in aquatic food-producing species.