(571) 447-5500

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 We saw during the drug listing certification period, that several labeler codes were reflecting outdated information.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

CDER & CBER

CDRH

CBER

Draft Guidance for comment purposes only

Importation of Certain FDA – Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

This guidance document is being distributed for comment purposes only.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draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance (FR Vol 84, No. 246; 23 Dec 2019).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This guidance document is being distributed for comment purposes only.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

FR Vol 85, No. 6

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.

FR Vol 84, No. 249

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 Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices.