Latest Federal Register Notices

Comments Sought Peptide Clin/Pharm Evaluations
5/14/2021 Federal Register notice: FDA has opened a public docket for comments on “Evaluating the Clinical Pharmacology of Peptides.” The agency is seeking comments on the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides as well as the effects of peptides on cardiac electrophysiology. Although FDA has been regulating peptides for decades, there is a desire for specific considerations on the design and conduct of clinical pharmacology studies to assess peptides, such as those designed to evaluate the effects of organ impairment or drug interactions. Currently, there are no FDA published guidance documents on clinical pharmacology assessments that contain specific recommendations for peptides. Public comments will help FDA develop recommendations for designing and conducting studies important to the safe and effective use of peptides and help with regulatory assessments of such studies. To view the notice, click here.

Panel to Hear Classifications for 6 Preamendment Devices
5/14/2021 Federal Register notice: FDA has announced a 6/3-4 meeting of the Medical Devices Advisory Committee’s Neurological Devices Panel. On 6/3, the panel will discuss and make recommendations on the classification of topical refrigerants (vapocoolants), which are currently unclassified preamendment devices, to Class 2 (general and special controls). It will also discuss and make recommendations on the classification of acupressure devices, which are currently unclassified preamendment devices, to Class 1. Additionally, panel members will discuss and make recommendations on the classification of electro-acupuncture stimulators, which are currently unclassified preamendment devices, to Class 2 (general and special controls). On 6/4, the panel will discuss and make recommendations regarding the classification of attention task performance recorders, which are currently unclassified preamendment devices, to Class 2 (general and special controls). Panel members will also take up the classification of optical contour sensing devices, which are currently unclassified preamendment devices, to class I (general controls), and the classification of plunger-like joint manipulators, which are currently unclassified preamendment devices, to Class 2 (general and special controls). To view the notice, click here.

Oncologic Panel to Vote on Incyte BLA
5/13/2021 Federal Register notice: FDA has announced a 6/24 Oncologic Drugs Advisory Committee that will discuss an Incyte BLA for retifanlimab injection. The proposed indication is for treating adult patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on from or who are intolerant of platinum-based chemotherapy. To view the notice, click here.

Guide on Drug Statistical Principles for Clinical Trials
5/12/2021 Federal Register notice: FDA is making available a final guidance entitled E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. The guidance was prepared under the auspices of the International Council for Harmonization to clarify, update, and extend a 1998 guidance entitled E9 Statistical Principles for Clinical Trials. Concerning estimands, it provides a framework for discussion of how the aims of a trial relate to the proposed statistical analysis. Concerning sensitivity analysis, it discusses how to use additional analyses to address concerns about the validity of assumptions underlying the main analysis. To view the notice, click here.