August 2019 Drug and Device Corner

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:

Annual Establishment facility fee rates effective 1 October 2019 are as follows:

  • Medical Device: $5,236

GDUFA

  • 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:

ALL DIVISIONS

CDER

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.

CDRH

CVM

  • 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.
Posted in 2019, 2019 September, Drug and Device Corner, EASeNews.