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Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA has recommended February for this report, currently there is no mandatory timing, other than during the calendar year. If you have questions or need support with this process, please reach out to EAS.

FDA Announces the Availability of Additional Submission Tools for Cosmetic Product Facility Registration and Cosmetic Product Listing The FDA announced the availability of SPL Xforms, an SPL authoring tool for cosmetic product facility registration and cosmetic product listing. Also announced was the availability of Form FDA 5066 and Form FDA 5067 which would be mailed to the FDA upon completion. Although physical forms are available, the agency highly recommends electronic submission of registration and listing information.

The FDA has created a database to conduct a Search for Pharmaceutical Quality Documents.

DRAFT Guidance Documents Available for Comment

Conducting Remote Regulatory Assessments Questions and Answers

FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs and help maximize compliance of FDA-regulated products.

Comments may be made to Docket Number FDA-2022-D-0810

Quality Considerations for Topical Ophthalmic Drug Products

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

Submit Comments by 26 February 2024

Requests for Reconsideration at the Division Level Under GDUFA

This draft guidance provides recommendations on the procedures for applicants of abbreviated new drug applications that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.

Submit Comments by 11 March 2024

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices

This draft guidance document provides the FDA’s recommendations on information to support premarket submissions for metallic coatings and/or calcium phosphate coatings on orthopedic devices. This guidance applies to metallic coatings, calcium phosphate coatings, or metallic and calcium phosphate dual coatings on orthopedic devices.

Submit Comments by 22 March 2024

CVM GFI #286 (VICH GL60) – Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products

This document provides guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

Submit Comments by 25 March 2024

Potency Assurance for Cellular and Gene Therapy Products

This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. A potency assurance strategy is a multifaceted approach that reduces risks to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. The goal of a potency assurance strategy is to ensure that every lot of a product released will have the specific ability or capacity to achieve the intended therapeutic effect.

Submit Comments by 27 March 2024

Highlighted Guidance Documents

Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry

This guidance is intended to assist applicants and holders of an ANDA in updating their labeling following revisions to the approved labeling of a reference listed drug. This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling. After it has been finalized, this guidance will replace the April 2000 guidance.

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

This guidance is intended to assist applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications, including requests for final approval. This guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fashion to enable final approval on the earliest date on which the ANDA may lawfully be approved based on patent and/or exclusivity protections.

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

This guidance document updates and clarifies the information regarding sterilization processes that the agency recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that the agency recommends sponsors include in a 510(k) submission. For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database Web site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

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

Federal Register

  • FR Vol. 89, No. 17 (4950), Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
  • FR Vol. 89, No. 17 (4952), Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
  • FR Vol. 89, No. 18 (5244), Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability


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