With the Over-The-Counter Monograph User Fee Program (OMUFA) 2021 facility user fee now past due, the FDA would like to remind all drug establishment manufacturers to make payment immediately. Please note the FDA has not issued invoices for this fee. The agency’s only communication, other than the initial Federal Register notice, would be an email alerting establishments of their past due obligation. The FDA has become aware of 3rd party entities sending fraudulent invoices. If you have any questions on this fee, or the payment process please contact Victoria Pankovich.
In preparation for FDA’s FY 2022 PDUFA program fee invoices, the Dear Colleague Letter (DCL) was emailed on Monday, May 3, 2021. Please submit your response to CDERCollections@fda.hhs.gov by Tuesday, June 1, 2021. If you have any questions regarding the DCL, please send an email to the Dear Colleague Letter Coordinator at CDERCollections@fda.hhs.gov.
As with all businesses and government agencies, the FDA experienced a disruption to their processes during the COVID-19 pandemic. The agency has published their Resiliency Roadmap for FDA Inspectional Oversight report which offers insight into their current thinking on how to achieve their inspectional activities without interruption going forward. The report offers information on the alternative tools and approaches which were implemented by FDA during the pandemic. The agency’s plan to get back to their standard operation levels of inspection activity, and modernization efforts for their data platforms are also covered. Further information can be found on the Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations website.
FDA Guidance Documents highlights
- Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19
- ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- Recently published Guidance Documents can be searched on the FDA’s website.
Federal Register notices of interest
- Vol 86, No 81 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055
- Vol 86, No 91 Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use. Comments may be submitted by 14 June 2021.
- Vol 86, No 92 Evaluating the Clinical Pharmacology of Peptides; Establishment of a Public Docket; Request for Information and Comments. Comments may be submitted by 13 July 2021.