Is your labeler code up to date?!? Chances are if you have not thought about this file since you originally requested a labeler code from the FDA, it could use an update. We saw during the drug listing certification period, that several labeler codes were reflecting outdated information. Keep in mind, your labeler code is attached to every single drug listing of your company. If the FDA needs to reach a company regarding an NDC number, they will use the contact information contained in the labeler code file. Perhaps your facility has moved? Is it possible the contact listed for your company when you applied for your labeler code has retired or moved on? If you have concerns, please reach out to EAS and we can confirm the information contained in your labeler code for you. You can reach Victoria Pankovich, EAS Regulatory Specialist at vpankovich@easconsultinggroup.com or +1-571-447-5506.
Guidance Document updates on the FDA website
CDER
- Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations.
- Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions [Broken Link] This final guidance helps sponsors of investigational new drug applications and applicants of new drug applications evaluate drug-drug interactions (DDIs) during drug development and determine essential information to communicate in labeling.
- In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions [Broken Link] This final guidance is intended to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product.2 The final guidance focuses on in vitro approaches to evaluate the interaction potential between investigational drugs with cytochrome P450 enzymes (CYPs) and transporters as well as how in vitro results can inform future clinical DDI studies.
CDER & CBER
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).
- Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Q & A The purpose of this guidance is to provide information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by section 505B(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only.
- Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 This guidance describes the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment.
- Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies.
CDRH
- Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions This draft guidance document provides draft recommendations, including bench testing and coating characterizations, for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons).
- Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions This guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data (often referred to as “radiological data” in this document).
CBER
Draft Guidance for comment purposes only
This guidance document is being distributed for comment purposes only.
This guidance describes recommended procedures to obtain an additional National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the Federal Food, Drug, and Cosmetic Act (21 106 U.S.C. 381). This guidance specifically addresses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed (hereinafter “multi-market approved product” or “MMA product).”
You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance (FR Vol 84, No. 246; 23 Dec 2019). Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 14 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
Requesting FDA Feedback on Combination Products
This guidance document is being distributed for comment purposes only.
The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms (generally the most efficient and effective approach), such as the pre-submission process used in CDRH and CBER and the formal meetings used in CDER and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance (FR Vol 84, No. 247; 26 Dec 2019). Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
This guidance document is being distributed for comment purposes only.
This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness. This guidance complements and expands on the 1998 guidance entitled Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (the 1998 guidance).
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance (FR Vol. 84, No. 245). Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
Federal Register notices of note
FR Vol 85, No. 9
21 CFR Part 890 [Docket No. FDA–2019–P–3347]
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
FDA’s CDER Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing
Requests for hearings by ANDA holders due to FDA by February 10, 2020. All data, information, and analysis serving as the basis for the hearing due to FDA by March 9, 2020.
Written comments due to FDA by March 9, 2020.
21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 [Docket Nos. FDA–2017–N–1129 and FDA– 2017–N–1610]
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Posted in Drug and Device Corner, Drugs, Medical Devices.