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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of a final guidance for industry titled “Facility Readiness: Goal Date Decisions Under GDUFA,” finalizing the draft guidance of the same title issued on October 7, 2022.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 on a 356h in an application is not ready for inspection, a 15 month goal date and deferred substantive assessment will be applied. This policy is intended to focus agency resources on substantially complete applications that contain facilities ready for inspection. The agency expects this policy to maximize the efficiency and utility of each assessment cycle. The guidance document contains specific information to be aware of. An important point to remember is the GDUFA III commitment letter also articulates that an application that contains a facility not ready for inspection 30 days prior to the original assigned goal date expiration, will have the goal date reset for an additional 15 months. See the guidance document for complete details.

FDA has issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the labeling of OTC internal analgesic, antipyretic, and antirheumatic drug products containing acetaminophen. The warning would alert consumers that the use of acetaminophen may cause severe skin reactions.

The comment period for this proposed administrative order began 14 June 2024. Because the FDA is currently experiencing issues with the commenting function, the comment period will be extended beyond 29 July 2024. See the Proposed Administrative Order OTC000035 – Amending OTCM013_06.14.2024.pdf for details and comment instructions.

Although the June period to align NDC listings has passed, drug listings can still be updated without waiting for the renewal period during October – December. A reminder that the following changes to a drug product require a new NDC product code assignment (the middle section): 1) The established name or proprietary name, if any; 2) The active ingredient or its strength; 3) The dosage form; 4) The drug’s status, between prescription and nonprescription, or for animal drugs, between prescription, nonprescription, or veterinary feed directive; 5) The drug’s intended use between human and animal; or 6) The drug’s distinguishing characteristics such as size, shape, color, code imprint, flavor, and scoring.

As noted by the FDA in their communication to registrants last fall, the agency updated the marketing category and application number fields for OTC monograph drugs in FDA’s Electronic Drug Registration and Listing System, to reflect section 505G of the FD&C Act. Per regulation “a final monograph or tentative final monograph that establishes conditions of use for a monograph drug that represents the most recently issued version of the conditions of use, including as modified, in whole or in part, by any proposed or final rule, is deemed to be a final order.” These orders are available on the OTC Monographs@FDA portal. For the marketing category field, the system replaced “OTC monograph final” and “OTC monograph not final” with the single term “OTC monograph drug”. For the application number field, the OTC monograph CFR Parts are no longer being referenced. Instead, if a drug is being marketed under a final order, please use the number of the applicable OTC monograph found on the OTC Monographs@FDA portal. Please review listings that were certified during the 2023 renewal but have not yet been updated in 2024 to reflect these new fields. Addressing this issue now will reduce the burden during the renewal period. EAS can support with this process, or assist with any questions that arise while complying.

OTC adjacent, the enforcement deadline for cosmetic facility registration and product listing is 1 July 2024. If you have not yet addressed this need, or you are having validation issues, EAS can assist. Reach out to Victoria Pankovich for support.

Highlighted Guidance Documents

Laboratory Developed Tests: Small Entity Compliance Guide

On May 6, 2024, FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests”. This final rule amends FDA regulations to make explicit that in vitro diagnostic products are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory. FDA has prepared this Small Entity Compliance Guide to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs.

DRAFT GUIDANCE Platform Technology Designation Program for Drug Development
Submit Comments by 07/29/2024

DRAFT GUIDANCE Considerations in Demonstrating Interchangeability With a Reference Product: Update
Submit Comments by 08/20/2024

DRAFT GUIDANCE Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
Submit Comments by 09/26/2024

DRAFT GUIDANCE Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
Submit Comments by 09/29/2024

DRAFT GUIDANCE Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
Comments may be submitted to Docket number FDA-2024-D-1243

DRAFT GUIDANCE Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products
Comments may be submitted to Docket number FDA-2024-D-1244

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

Federal Register

Federal Register Vik 89, No, 118 Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases

Federal Register Vol 89, No. 120 Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability

Federal Register Vol 89, No. 120 Human User Safety in New and Abbreviated New Animal Drug Applications; Guidance for Industry; Availability

Federal Register Vol 89, No. 120 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Guidance for Industry; Availability

Federal Register Vol 89, No. 121 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062

Federal Register Vol 89, No. 122 Laboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability


Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method
Date: July 10, 2024
Time: 1:00 PM – 2:30 PM ET

Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products
Date: July 11 – 12, 2024
Day1: Thu, Jul 11 9:00 AM – 5:00 PM ET
Day2: Fri, Jul 12 9:00 AM – 1:00 PM ET

Webinar – In Vitro Diagnostic Product (IVD): Classification
Date: July 16, 2024
Time: 1:00 PM – 2:00 PM ET

FDA Announces First Annual Animal Drug User Fee Educational Conference
July 17, 2024, from 9 a.m. to 5 p.m. Eastern Time. Attendees can join in-person or virtually

Public Workshop: Best Practices for Meeting Management Under PDUFA VII
Date: July 22, 2024
Time: 9:00 AM – 2:00 PM ET

Introduction to FDA’s Office of Trade and Global Partnerships – 07/23/2024 | FDA
Date: July 23, 2024
Time: 1:00 PM – 2:00 PM ET

FDA’s Fifth Online Controlled Substances Summit
Date: July 25 – 26, 2024
Day1: Thu, Jul 25 11:00 AM – 3:00 PM ET
Day2: Fri, Jul 26 11:00 AM – 4:00 PM ET

Environmental Monitoring in Compounding
Date: July 30, 2024
Time: 2:00 PM – 3:30 PM ET

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