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On 29 December 2022, the U.S. President signed H.R 2617 – the Consolidated Appropriations Act, 2023 into law which includes the Food and Drug Omnibus Reform Act.  Of particular interest in this legislation for EAS drug and device clients, are the following:

  • The FDA will establish a waiver of Medical Device establishment registration user fees for small businesses for whom the fee would present a financial hardship for that particular year
  • Establishment of a pilot program for unannounced routine surveillance inspections of foreign human drug establishments
  • Significant changes to the FD & C Act regarding cosmetic product regulation

EAS will keep our clients informed of 21 CFR updates, and release of Guidance Documents resulting from this new legislation.

A note for EAS drug clients that also manufacture cosmetic products, we will be sharing information as it becomes available on the newly established FDA requirements for cosmetics.  If you do not typically receive communications from EAS for cosmetic products, please contact Victoria Pankovich to request inclusion in our upcoming communications and webinar invitations.

Guidance Documents of Interest

Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

The purpose of this guidance is to assist applicants in ensuring that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. The agency is withdrawing the guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products–Content and Format” issued on March 29, 2010, and issuing this draft guidance.

Format and Content of a REMS Document Guidance for Industry

This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product.

REMS Document Technical Conformance Guide

This Guide supports submission of a REMS Document in Structured Product Labeling (SPL) format. In addition, this Guide provides an outline to assist applicants in drafting a Bifurcated REMS Document.

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

Federal Register

FR Vol 88, No. 13 Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products

FR Vol 88, No. 15 Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period

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