(571) 447-5500
The FDA published a new Guidance DocumentAlternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications which articulates the agency’s evolving policy which has grown from the Pandemic era use of alternative tools in evaluating drug manufacturing facilities identified in applications. The alternative tools discussed in the guidance do not apply to post-approval, surveillance, compliance, or bioresearch monitoring inspections. These tools are used under a risk based approach in support of, or in lieu of an inspection. The guidance is clear that facilities cannot request alternative tools, the agency will decide when the use of alternative tools is appropriate on a case by case basis. Full details can be found in the guidance.

Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact Victoria Pankovich at EAS.

On Friday 13 October 2023, the FDA issued an update to the Structured Product Labeling (SPL) Implementation Guide with Validating Procedures. The cosmetic section can be found in “3.4 Cosmetic Products” located on page 95 of the guide.

As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA. If you do not already have an FEI (FDA establishment identifier), you should take steps to obtain yours as soon as possible. EAS can help if needed.

The FDA is now accepting Over-the-Counter Monograph Order Requests (OMORs) via the CDER NextGen Portal. The agency made the following guidance documents available to assist with the process.

Providing Over-the-Counter Monograph Submissions in Electronic Format (Sept 2022)

Over-the-Counter Monograph Order Requests: Format and Content (April 2023)

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs (February 2022)

FDA has updated the address for user fees delivered by courier, such as Federal Express or UPS. Beginning October 6, 2023, to prevent any disruption of overnight packages, please send any payment arriving via courier to:

U.S. Bank
Attention: Government Lockbox 979108
3180 Rider Trail South
Earth City, MO 63045

This address change does not affect electronic payments. Additional information regarding cover sheets and available payment methods is available at www.fda.gov/gdufa, in the Payment Information and Cover Sheet section.

If you have any questions concerning courier delivery, please contact U.S. Bank at 800-495-4981.

FDA Announces FY 2024 Animal Drug User Fee Rates for ADUFA and AGDUFA

Draft Guidance Documents Open for Comment

DRAFT: Quality Considerations for Topical Ophthalmic Drug Products

This guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

Comments may be submitted by 12 December 2023.

DRAFT: Electronic Submission Template for Medical Device De Novo Requests

FDA is issuing this draft guidance document to introduces submitters of De Novo requests to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA.

Comments may be submitted by 28 November 2023

DRAFT: Diabetic Foot Infections: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFIs) without concomitant bone and joint involvement.

Comments may be submitted by 18 December 2023

Highlighted Guidance Documents

Electronic Submission Template for Medical Device 510(k) Submissions

This guidance provides the standards for the submission of 510(k) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This document supersedes the final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” issued October 2, 2014.

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol

This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol.

Benefit-Risk Assessment for New Drug and Biological Products

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the FDA makes about NDAs and BLAs.

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.

Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”

This guidance provides recommendations for incorporating dose banding information into the labeling of an injectable drug product that is seeking approval through a new drug application, a biologics license application, or a supplement to one of these approved applications.

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

Federal Register

Federal Register Vol 88, No. 200, Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability

Federal Register Vol 88, No. 190, Medical Devices; Laboratory Developed Tests


Virtual Public Workshop – Extended Reality in Orthopedic Surgical Devices: Insights into User Experience and Adverse Event Reporting for Patient Safety

Date: Thursday 2 November 2023
Time: 9:00 AM – 1:00 PM EST

Electronic Submission of Adverse Event Reports using ICH E2B (R3) standards

Date: Tuesday 7 November 2023
Time: 9:00 am – 12 pm EST

Common Issues with SEND Data Submitted for Safety Pharmacology Studies

Date: Thursday, 16 November 2023
Time: 1:00 PM – 2:30 PM ET

Toward Global IDMP Implementation: A Focus on Global Use Cases

Date: Tuesday 28 November 2023
Time: 1:00 PM – 2:30 PM EST

FDA Clinical Investigator Training Course (CITC) 2023

Dates: Wednesday and Thursday 6-7 December 2023

Day1: Wed 6 Dec, 11:00 AM – 4:30 PM EST
Day2: Thu, 7 Dec, 11:00 AM – 4:00 PM EST

A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Workshop

Dates: Tuesday – Thursday, February 13 – 15, 2024

Day1: Tue 13 Feb, 8:30 AM – 3:35 PM EST
Day2: Wed 14 Feb, 8:30 AM – 3:50 PM EST
Day3: Thu 15 Feb, 8:30 AM – 4:50 PM EST

Non-FDA Website of Interest

15th Annual Sentinel Initiative Public Workshop

Duke-Margolis Center for Health Policy will host the 15th Annual Sentinel Initiative Public Workshop under a cooperative agreement with the Food and Drug Administration

Date: Wednesday 8 November 2023
Time: 9:00 am – 5:00 pm EST

Posted in Drug and Device Corner.