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 The marketing categories “OTC monograph final” and “OTC monograph not final” are no longer valid.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 can be found on FDA’s OTC MONOGRAPHS @ FDA website. SPL files identifying the CFR reference rather than the OTC monograph will no longer validate in the system, and these NDC listings will not be available for certification. If you have questions or need support, reach out to Victoria Pankovich at EAS Consulting Group.
Highlighted Guidance Documents
Control of Nitrosamine Impurities in Human Drugs
The FDA is announcing the availability of a final guidance for industry entitled “Control of Nitrosamine Impurities in Human Drugs.” This guidance recommends steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance describes two general structural classes of nitrosamine impurities: small-molecule nitrosamine impurities (i.e., nitrosamine impurities that do not share structural similarity to the API), and nitrosamine drug substance-related impurities (NDSRIs), which share structural similarity to the API and are generally unique to each API. The guidance discusses the potential root causes of the presence of nitrosamine impurities, detection of nitrosamine impurities, and recommendations for risk assessments, testing, and implementation of controls and other appropriate strategies to prevent or reduce the presence of nitrosamine impurities in APIs and drug products. Recommendations for an alternative bioequivalence approach if manufacturers and applicants decide to reformulate their products to mitigate nitrosamine impurities are also provided in the guidance. This guidance revises the final guidance of the same name issued on February 24, 2021.
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments to either ANDAs or PASs submitted to the Food and Drug Administration under section 505(j) of the FD&C Act. This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s assessment goal dates. This guidance supersedes the July 2018 guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.
Under section 745A(a) of the FD&C Act, at least 24 months after the issuance of a final guidance document in which the FDA has specified the electronic format for submitting submission types to the Agency, such content must be submitted electronically and in the format specified by FDA. This guidance describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. This guidance also references several technical specification documents and the electronic common technical document Technical Conformance Guide, which provide additional details regarding the organization of content for electronic submissions.
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
FDA is issuing this guidance to help manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting (VMSR) Program, an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to FDA in a summary format on a quarterly basis. FDA’s VMSR Program is intended to yield benefits for both FDA and the public, such as increasing transparency for the public, helping FDA to process certain malfunction reports efficiently, allowing both FDA and the public to identify malfunction trends more readily, and reducing the burden on manufacturers. This guidance is intended to explain, but not change, the conditions of the VMSR Program.
Study Data Technical Conformance Guide – Technical Specifications Document
This technical specifications document represents the FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Conducting Clinical Trials With Decentralized Elements
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers. In this guidance, a decentralized clinical trial refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.
DRAFT CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies
Submit Comments by 11/18/2024
DRAFT Chemical Analysis for Biocompatibility Assessment of Medical Devices
Submit Comments by 11/18/2024
Submit Comments by 12/17/2024
Submit Comments by 12/17/2024
All Guidance Documents can be searched on the FDA’s website.
Federal Register
Federal Register Vol 89, No. 180 Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices
Federal Register Vol 89, No. 180 Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability
Meetings
Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products
Date: October 3, 2024
Time: 8:30 AM – 12:30 PM ET
ICH M12 Drug-Drug Interaction Studies Final Guidance
Date: October 9, 2024
Time: 1:00 PM – 3:00 PM ET
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
Date: November 7, 2024
Time: 1:00 PM – 2:30 PM ET
FDA Websites of Interest
- Upcoming Product-Specific Guidances for Generic Drug Product Development
- Medication Guide: Patient Medication Information (PMI), Proposed Rule
- CDERLearn
- The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
- Streamlining Drug Development and Improving Patient Care: CDER Quantitative Medicine Center of Excellence
Posted in Drug and Device Corner, Drugs, Medical Devices.