Drug and Device Corner

Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. 2025 reports are due no later than 31 March 2026. Reminder that the agency began their policy enforcement late in 2025 contacting facilities that had not reported all NDC volumes. If you have questions or need support with this process, please reach out to EAS.The agency began their email reminders to registered cosmetic facilities RE submittal of their biennial renewals. Keep in mind...

Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the blanket no change certification period, which ends on 31 December, will need to submit a listing update in January to avoid inactivation of the NDC by the agency. Each individual SPL file will need to be submitted.EAS has received...

For those not already aware, the US government shutdown has ended. The User Fee system is now open and accepting FY2026 payments.The first step for renewal of your Medical Device facility is to pay the FDA FY2026 Medical Device Annual Establishment Registration User Fee of $11,423. This process will generate the necessary PIN / PCN numbers which will be required for the registration renewal. If you have questions on how to process the payment, do not hesitate to reach out to EAS. Reminder that...

REMINDER: The drug and medical device establishment registration renewal and listing certification period begins 1 October 2025. EAS is here to assist our clients with this process, do not hesitate to reach out if you need support.The agency has published their final guidance document “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications”. During the COVID-19 pandemic when in person inspections for drug application marketing approval was not possible,...

Generic Drug User Fee Amendments (GDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due 1 October 2025.  User Fee Type FY 2026 ANDADMF $ 358,247$ 102,584 Program Large SizeMedium SizeSmall Size $ 1,918,377$ 767,351$ 191,838 Facility Domestic APIForeign APIDomestic FDFForeign FDFDomestic CMOForeign CMO $ 43,549$ 58,549$ 238,943$ 253,943$ 57,346$ 72,346 Medical Device User Fee Amendments (MDUFA) 2026 user fees were published in the 30 July...

The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA regulated products will be reviewed upon import, regardless of quantity or value. With this heightened scrutiny, ensuring all regulations are complied with (labeling, registrations, product listings, etc) is crucial. If you need support...

The FDA has released two proposed administrative orders for requesting minor dosage form changes to certain OTC monograph drugs. These administrative orders are open for comment. Proposed Administrative Order OTC000038 If finalized, this proposed order will specify requirements for industry to make minor dosage form changes to certain OTC monograph drugs. The changes covered would be from tablets and capsules to chewable tablets, orally disintegrating tablets, or films. The agency believes...

Reminder that OMUFA FY2025 facility user fees are due Monday 2 June 2025. MDF fee is $37,556; CMO fee is $25,037. Please see the FDA website for full details. Do note below the agency will be providing an OMUFA user fee and registration webinar Tuesday 20 May 2025.FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities in their effort to ensure products regulated by the agency are compliant with requirements and safe for U.S. consumers. Do note, the FDA may...

Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These submissions are made during the month of May The following types of generic industry facilities, sites, and organizations are required to self-identify with FDA: Facilities that manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both. Facilities that package the FDF of a human generic drug into the primary...

The 2025 OMUFA facility user fees have been announced in the Federal Register (see link below). Facility User Fee Rates FY 2025 Monograph Drug Facility (MDF) Fee $37,556 Contract Manufacturing Organization (CMO) Fee $25,037 The background and legislation on this program can be reviewed on the FDA’s website. The 2025 facility user fees are due no later than Monday 2 June 2025. If you have questions or need assistance processing your cover letter, please reach out to Victoria Pankovich at EAS....

Reminder that CARES volume reports for 2024 are due no later than 31 March 2025. If you need assistance with the process, EAS is here to help.The FDA has updated the OTC MONOGRAPHS @ FDA website’s OTC Monograph Resources section.  This includes a digital Catalogue of Pre-OMUFA Documents dataset in a downloadable excel spread sheet.  This catalogue includes a list of documents that were only accessible as paper documents prior to the passage of the Coronavirus Aid, Relief, and Economic Security...

Effective January 20, 2025, The President issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries. The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any rulemaking or similar regulatory activity until the new administration has had an opportunity to review what the previous administration proposed or promulgated. In this case, the order: Precludes federal agencies from proposing or...

The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user completes an ACNU demonstrating that the drug is appropriate and safe for that consumer. An example of an “additional condition” could be a questionnaire to determine if the drug product is right for the consumer. The final rule...

This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024.  If you need help with your submissions, please reach out to EAS for support. There were quite a few Warning Letters published in November issued by CDER for sightings related to CGMP/Finished Pharmaceuticals/Adulterated. EAS can provide a cGMP audit of your facility to assist...

Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact Victoria Pankovich at EAS. The U.S. recently suffered devastating hurricanes which affected the availability of certain intravenous and peritoneal dialysis solutions in the United States. As a result, the FDA has announced the...

The FDA Drug and Medical Device Registration renewal period begins 1 October 2024. With the drug listing certification period upon us, it is a good time to confirm your NDC listings are all accurate.  Any NDC SPL file requiring updates should be done prior to 31 December 2024.  The marketing categories “OTC monograph final” and “OTC monograph not final” are no longer valid.  For OTC monograph drug listings, the correct monograph citation needs to be entered during this renewal period. These...

FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory. The FDA had previously announced that drug facilities that first registered during the COVID-19 pandemic solely for the purpose of providing hand sanitizer products during the public health emergency were not identified as...

Final reminder that CARES Act drug amount reports for 2023 are due by 31 July 2024. If you need assistance with this process, reach out to Victoria Pankovich for support.The FDA announced the availability of a final guidance for industry titled “Facility Readiness: Goal Date Decisions Under GDUFA,” finalizing the draft guidance of the same title issued on October 7, 2022. With GDUFA III, the FDA has agreed to incorporate facility readiness into goal date assignments. If a facility identified...

Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of receiving such report. Cosmetic labels are required to include a domestic address, domestic phone number, or electronic contact information as of 29 December 2024.  This contact information is necessary for end users to report any adverse events.  Reach out to EAS if you have any questions. Although NDC...

FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024.  The facility fees for FY 2024 are due on 3 June 2024. Regarding fee specifics, Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $34,166 Owners of a contract manufacturing facility will pay 2/3 of the full fee:...

Reminder that CARES volume 2023 reports are due no later than 1 July 2024.Highlighted Guidance Documents Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide FDA is issuing this Technical Conformance Guide to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and...

The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very detailed instructions for submitting volume information. The agency also sheds light on the need for these reports. The CARES Act passed on 27 March 2020, requires each drug establishment registrant to report annual amounts of drugs...

Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be updated and submitted to reactivate the listing. If you need assistance with the process, or would like EAS to handle this for you, please contact Victoria Pankovich. FDA has issued a Draft Guidance “Remote Interactive Evaluations...