FDA Issues New User Fees for 2023-2024 – Costs Are Going Up! If you are submitting an NDA or BLA application that includes clinical data in 2023 or 2024, you will pay $3.24M, and a whopping $4.04M, respectively!  Program fees are also up: $393,933 in 2023 and $416,734 in 2024.

Organizations submitting DMFs can also expect to pay more in 2023 and 2024: $78,293 and $94,682 for the application fee.

ANDA user fees have also increased: $240,582 in 2023 and $252,453 in 2024.

You may be eligible for a user fee and/or program fee waiver under certain circumstances.  Talk to Facet to find out more!

FDA MIDAC Meeting Discussing Waiving Nonclinical Dosimetry Studies for Novel PET Products With Certain Radionuclides On August 1, 2023, FDA’s Medical Imaging Drugs Advisory Committee met to discuss the requirement for Sponsors to conduct animal dosimetry studies prior to IND submission for a first-in-human (FIH) clinical study for new 18F, 11C, 68Ga, 64Cu, 82Rb, and 13N PET drugs.  FDA regulation [21 CFR 312.23(a)(10)(ii)] requires that sufficient data from animal studies is needed to allow reasonable estimation of the absorbed whole body and critical organ doses of drugs in humans.  However, FDA approvals of a multitude of PET radiopharmaceuticals have yielded considerable information about the human radiation whole body and critical organ exposures for these radionuclides.  In the MIDAC meeting, FDA presented results from a systematic review of animal and human dosimetry data as well as safety data from currently approved PET products.  They concluded that if the proposed administered activity for a FIH study with a new PET drug radiolabeled with 18F, 11C, 68Ga, 64Cu, 82Rb, and 13N is less than or equal to 299 MBq (8 mCi), 555 MBq (15 mCi), 158 MBq (4.3 mCi), 148 MBq (4 mCi), 1440 MBq (39 mCi), and 552 MBq (15 mCi), respectively, adequate information exists which justifies omission of preclinical dosimetry studies.  In general, the panel agreed, although there was some concern about 64Cu due to a longer half-life and less data compared to the other radionuclides.  FDA and the advisory committee agreed that clinical dosimetry studies should occur as soon as possible in Phase 1 and be conducted with 6-20 patients.

FDA Rolls Out Revision to Draft Guidance on Formal Meetings  In September, FDA issued Revision 1 to their draft guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. The updated guidance provides timelines for all interactions with FDA and outlines 2 new meeting types: Type D and INTERACT (INitial Targeted Engagement for Regulatory Advice on CDER and CBER producTs).  Type D meetings are intended to be meetings that focus on a limited number (not more than 2) of issues (e.g., follow up questions after a formal meeting, general questions around an innovative development approach).  INTERACT meetings, which replace the “pre pre-IND” meeting, are designed for novel products and novel situations which raise challenging or complex development situations (e.g., advice on study designs for first-in-human trial in a novel disease state for which there is no precedent or guidance, selection of appropriate animal model(s) or toxicology study designs, novel CMC issues or testing not covered by existing regulation, guidance, or regulatory precedent). The guidance also discusses the difference between in person face-to-face meetings versus virtual (Zoom) face-to-face meeting formats.  Finally, the guidance stipulates that within 20 calendar days of receiving written responses (in the case of a WRO meeting) or FDA’s official meeting minutes, Sponsors may submit a “Request for Clarification” as a follow-up to make sure FDA feedback is fully understood.  FDA’s clarifying response can be expected within 20 calendar days of the Request.  At Facet, we are delighted to see FDA formalize a time-bound process for such feedback because Sponsors often want to ask clarifying questions after receiving FDA’s written responses (in the case of a WRO meeting) or formal meeting minutes.

FDA Warning Letter Uptick Related To Failure to Submit IND, Follow Investigational Plan, Lack of IRB Oversight  This year, there has been an uptick in the number of FDA 483 warning letters issued to investigators for failing to submit an IND to support the conduct of a clinical investigation of a drug.  With a few exceptions, a clinical investigation in which a drug is administered to human subjects must be conducted under an IND as required in 21 CFR 312 and comply with all FDA regulations and guidances.  Exceptions include certain clinical investigations of a marketed drug.  FDA has an excellent guidance on this topic, Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND, which was issued in September 2013.  If you are not sure your research requires an IND, reach out to Facet for an expert opinion.

FDA Final Guidance on Breakthrough Devices Program On September 15, FDA issued the guidance: Breakthrough Devices Program.  FDA’s Breakthrough Devices Program is intended to expedite development, assessment, and review of certain medical device and device-led combination products that diagnose, treat, or prevent life-threatening or irreversibly debilitating diseases or conditions.  The Breakthrough Devices Program replaces the Expedited Access Pathway and the Priority Review Program, but all devices with Breakthrough Device status should receive priority review.  The guidance includes information about the fundamentals of the program, how to submit a designation request, and helpful examples.  What is particularly interesting is that FDA has expanded the Breakthrough Devices Program to include certain devices that benefit populations impacted by health and/or healthcare disparities and certain non-addictive medical products to treat pain or addiction. If you are developing a medical device that you think may qualify for the Breakthrough Device program, contact Facet today for help in securing this highly sought after regulatory asset for your medical device.