Drug and Device Corner

Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline deems any generic drugs marketed by a company on the arrears list as misbranded. The drug establishment registration renewal and drug listing certification period begins 1 October 2023. The FDA will be updating two fields this...

We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have.  If you wish for us to handle the annual requirements, please email Victoria Pankovich to get on the schedule. The annual renewal and certification period runs from 1 October – 31 December.The FDA has announced FY2024 GDUFA user fee rates in the Federal Register Vol 88, No. 144.  Notable fees: DMF $94,682; Domestic API...

Thinking about an FDA gap assessment this year? Contact EAS now to schedule your 2023 audit. Schedules toward the end of the year tend to book up suddenly, now is the time to lock in your audit, whether it be onsite or virtual. We would be happy to prepare an audit proposal so you can review and schedule prior to Dec 2023. The FDA is stepping up enforcement of their Electronic Registration and Listing Compliance Program which is in place to ensure accurate drug establishment registration, and...

The FDA has published a new Guidance Document Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 which explains in great detail the GDUFA program user fee obligations. GDUFA III made slight changes to the user fee structure. (API facility fees changed from 7% to 6% and the GDUFA program fee changed from 35% to 36% of total revenue. Additionally the CMO facility fee has been decreased to 24% of the FDF fee, where it used to be 1/3) More importantly, the guidance explains...

As we approach June, keep in mind that drug establishment registrations and NDC listings that have had any changes to their information must update their files with the FDA within 30 days. Failing that, the agency expects updates to be submitted the JUNE or December following such a change. Do make sure your registration and listing information is up to date. If you need any assistance with the process, please reach out to EAS. (vpankovich@easconsultinggroup.com /...

Reminder that the FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility Fee: $17,435. The annual fee is due no later than 1 June 2023.Under GDUFA, human generic drug facilities, sites, and organizations are required to submit identification information electronically to FDA annually. These...

The FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility Fee: $17,435. The annual fee is due no later than 1 June 2023. EAS’ webinar An Introduction to Upcoming Modernization of Cosmetics Regulation Act (MoCRA) is available for viewing for anyone that may have missed this informative presentation by...

The FDA sent email reminders in February re mandatory CARES annual reporting for drug establishments, which are due now. CARES volume reporting has been an annual requirement since passing of the CARES Act in 2020. If you have not already submitted your 2020 and 2021 reports, do plan to submit these as well. EAS is here to support our clients if needed. For those following the new MoCRA regulations, EAS is recommending that cosmetic facilities falling under the new regulation proceed with...

On 29 December 2022, the U.S. President signed H.R 2617 - the Consolidated Appropriations Act, 2023 into law which includes the Food and Drug Omnibus Reform Act.  Of particular interest in this legislation for EAS drug and device clients, are the following: The FDA will establish a waiver of Medical Device establishment registration user fees for small businesses for whom the fee would present a financial hardship for that particular year Establishment of a pilot program for unannounced...

We wish you all a very happy holiday season and prosperous new year. Reminder of the deadline of 31 December 2022 for the establishment registration and product listing renewal period. For those that have not already submitted their CARES Act reporting for FY2020 and FY2021, do note per the regulation these reports are due. Although the FDA proposed dates for submission of these reports were non-binding, the reports themselves are indeed required. If you need assistance with the process,...

Reminder that December is the deadline for the establishment registration and product listing renewal period. Kindly note the FDA has tightened up their validation process for drug listings. Although repack / relabeled listings have been submitted in the past without source NDC identification, this is no longer possible. Source NDCs must be included with all repack / relabel NDC listings. Also note, the FDA is now verifying business processes of all identified establishments in NDC listings....

As many are aware, FY2023 FDA user fees were pending authorization from Congress which did not happen until 30 September 2022. As a result, the user fees were announced in early October 2022. Please see Federal Register links and screen shots of fee tables below.Federal Register Vol 87, No. 195 announcing FDA 2023 GDUFA user fee rates Table 1—Fee Schedule for FY 2023 Generic drug fee category Fees rates for FY 2023 Applications Abbreviated New Drug Application (ANDA) $240,582 Drug Master File...

As of 26 September 2022, the U.S. Congress has yet to pass the FDA user fees bill for FY2023 which begins 1 October 2023. EAS will keep our client based informed as this situation develops.EAS wishes to announce the retirement of Ms. Susan Crane, EAS Independent Advisor OTC Drugs and Labeling. We thank Susan for her outstanding support of EAS clients and our staff over the years and wish her much happiness in her retirement. Beginning 30 September 2022, please send any requests for service to...

Reminder that the establishment registration and product listing renewal period begins 1 October 2022.  Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle this process for you. We can pre-schedule an appointment in October, November, or December to be ready to proceed on your schedule. Guidance Documents of Interest Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies ​​This draft guidance will assist prospective ANDA...

EAS bids a fond farewell to Mr. Bryan Coleman, and welcomes Mrs. Lisa El-Shall as our new Sr. Director Pharmaceutical and Medical Device Consulting Services. Lisa can be reached at lelshall@easconsultinggroup.com, 571-447-5504.The FDA has finalized the UDI draft guidance document originally published 14 October 2021, which will supersede the guidance issued on 1 July 2020. Federal Register Vol. 87, No. 141 “Unique Device Identification: Policy Regarding Compliance Dates for Class I and...

The FDA is tightening up the validation process in their NDC drug listing system CDER Direct. Prior to 2022, Relabelers and Repackers were able to list their products NDC/label without identifying the source NDC. As of 2022, the drug listing of a repackaged or relabeled product will fail validation without the source NDC identified. The Source NDC is the code of the drug product being relabeled or repackaged. Currently, the unit of measure must match (source and relabel/repackage listing). As...

The passing of the CARES Act in 2020, built on the authorization given to FDA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), to address the problem of drug supply disruptions and shortages. The agency released a draft guidance to assist stakeholders in developing a Risk Management Plan (RMP) for certain prescription drug products, APIs and supporting medical device products. A framework developed for an RMP should be in line with ICH Q9, as per FDA most...

We are 5 months out from the UDI / GUDID enforcement date of 22 September 2022 for Class I and unclassified devices, are your processes in place? Do you know what requirements are applicable to your operation? Helpful information can be found on FDA’s webpage GUDID Guidance, and in the Guidance Document titled: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. As your regulatory partner, EAS is here...

FDA announced the fiscal year 2022 OTC-Monograph Drug User Fee rates in the Federal Register Vol 87, No 51 published today 16 March 2022. These fees cover FDA’s FY2022 which runs from October 2021 through September 2022. The facility fees for FY 2022 are due on 1 June 2022 Regarding fee specifics, Owners of manufacturing and processing facilities of finished OTC-drug dosage forms will pay a full facility fee: $24,178 Owners of a contract manufacturing facility will pay 2/3 of the full fee:...

FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments” On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes. If finalized, the new regulation will be called the Quality Management System Regulation. The public comment period is open for 90...

 Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD submissions via ESG, please note that beginning 1 March 2022, all submissions using eCTD Module 1 U.S. Regional DTD must be version 3.3. As of March 1st, any submission using eCTD Module 1 U.S. Regional DTD Version 2.01 will be...

REMINDER CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 Cover Letter Attachments for Controlled Correspondences and ANDA Submissions The FDA has created check lists to be used, at applicant’s discretion, to assist in creating cover letters for Controlled Correspondence, and Abbreviated New Drug Application submissions....

Final reminder that we are entering the last month of the registration renewal period for medical device facilities and drug establishments, as well as drug listing certifications. The FDA has provided an Electronic Drug Registration and Listing Instructions website for support. Clients wishing to have EAS handle these submissions for them, please contact Victoria. CARES Act Drug Shortage Mitigation Efforts For those not already aware, the CARES Act expanded the FD&C Act to require drug...

REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period. The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based Hand Sanitizers. With a thank you to all companies who entered into the market to supply hand sanitizer during the health emergency, the FDA notes there is now a sufficient supply available, and there is no longer a need to provide...

As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance in manufacturing to the CDRH. The list of relevant devices can be found on this FDA website. A Guidance Document was implemented for the duration of the current health emergency. The agency has developed an online webform to submit these notifications. Also provided to assist manufacturers with this...

FDA has announced most FY2022 user fee rates this month, conspicuously missing are the OMUFA 2022 user fee rates. We will continue to monitor Federal Register notices and share information as soon as it becomes available. Federal Register Vol. 86, No. 142 announcing FDA 2022 GDUFA user fee rates Fee category Fees rates for FY 2022 Applications: Abbreviated New Drug Application (ANDA) $ 225,712 Drug Master File (DMF) 74,952 Facilities: Active Pharmaceutical Ingredient (API)—Domestic 42,557...

The FDA has planned a public webinar titled Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency. Please follow the link to register for this webinar scheduled for 25 August 2021. Recently published in the Federal Register, FDA has issued their final determination regarding Class I Surgeon's and Patient Examination Gloves. This notice clarifies the confusion caused by two conflicting notices previously published in the Federal Register. Per this final...

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...

After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC drug manufacturing facility user fees. The announcement also reiterates previously shared information for OTC Monograph Order Requests, although the FDA does not yet have a system in place to process such an order. For the time...