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The FDA has published the OMUFA Arrears list on their OTC Monograph User Fee Program webpage, with information as of 11 June 2021. In addition to establishments being named on the arrears list, drugs manufactured at facilities that have not satisfied their OMUFA FY2021 obligation are deemed misbranded.  The agency also published an OMUFA fee-related Q & A webpage to share information. If your firm is reported on the arrears list, and you need support, please contact EAS for guidance.  You may also watch the FDA’s OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees webinar recording for further information on this new user fee program.

With the introduction of drug listing certification several years ago, the FDA has heightened their surveillance of electronic drug establishment registration and drug listing data. EAS has seen listings that have been inactivated by the FDA for either failure to certify during the drug certification period, or inaccurate data submitted. Now is a good time to review your listings and confirm they are accurate and remain active on the FDA’s National Drug Code Directory and DailyMed.

In a sign that things are moving in the right direction, the FDA is beginning to scale back their pandemic guidance regarding PPE, specifically the use of Non-NIOSH-Approved Respirators.  With the supply of NIOSH approved respirators increasing, the agency believes crisis capacity conservation strategies are no longer necessary. FDA is effectively not accepting EUA Requests for these devices and would expect these devices to pursue the routine 510(k) pathway to approval.

The FDA recently sent an email to all users of the CDER Direct NextGen portal as a reminder that beginning June 24, 2021, the following submission types will be mandatory in eCTD format and may only be submitted through the Electronic Submissions Gateway (ESG) 

  • FDA Form 2253
  • Accelerated Approval Pre-submissions

Consequently, these submission types will not be accepted via the NextGen portal.  All other submission types to OPDP will be accepted eCTD format but there is no requirement to do so. Refer to the OPDP electronic submissions guidance for details on eCTD submissions to OPDP.

In the Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance Document issued in August 2020, the FDA’s CDER, CBER and CDRH divisions’ describe their current thinking on levying civil money penalties against any responsible party and / or submitter who neglect to submit registration and / or results information to the ClinicalTrials.gov data bank. The agency notes that many responsible parties voluntarily comply with the law, and for those the FDA identifies that have not done so, a Pre-Notice of Noncompliance is issued. On April 28, the FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. Although the agency gives the company 30 days to bring their reporting into compliance, the FDA notes their authority to seek civil money penalties for the violation.

Recently Published Guidance Documents of Note

On the website FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain the agency offers insight into DSCSA. The agency feels their efforts thus far have created a robust program of preventing and detecting illegitimate products in the supply chain.  FDA is releasing several guidance documents to aid industry in understanding DSCSA requirements and compliance. Additionally, the agency is looking for feedback on ways to further improve drug supply chain operations within the DSCSA framework.

Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order

The purpose of this draft guidance document, when finalized, is to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval.

Postmarket Surveillance Under Section 522 of the Federal FD and C Act

This draft guidance document, when finalized, will assist manufacturers of devices subject to section 522 postmarket surveillance orders

Recently published Guidance Documents can be searched on the FDA’s website.

Posted in Drug and Device Corner, Drugs, Medical Devices.