Latest Federal Register Notices
Allergenic Products Panel to Hear Research Overview
9/10/2021 Federal Register notice: FDA has announced a 10/28 Allergenic Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs in CBER’s Laboratory of Immunobiochemistry. To view the notice, click here.
Workshop on Opioid Prescriber Education Under REMS
9/10/2021 Federal Register notice: FDA has announced a public workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.” Convened by the Duke-Margolis Center for Health Policy, the workshop is intended to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS. To view the notice, click here.
Draft ICH Gene Therapy Guide
9/9/2021 Federal Register notice: FDA has made available a draft guidance entitled S12 Nonclinical Biodistribution Considerations for Gene Therapy Products. The International Council for Harmonization document provides recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy products. It also offers considerations for interpreting and applying the BD data to support a nonclinical development program, including clinical trial designs. To view the notice, click here.
Comments Reopened on ICH Q12 Guidance
9/9/2021 Federal Register notice: FDA is reopening the comment period on a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products. Comments can be submitted until 10/12. To view the notice, click here.
Info Collection on FDA Communications Testing
9/8/2021 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications” (OMB Control Number 0910-0865). The collection allows FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers’ reactions to agency communications or educational messaging. To view the notice, click here.
Proposals Sought for Drug Excipient Pilot
9/7/2021 Federal Register notice: CDER is announcing its Novel Excipient Review Pilot Program. The voluntary pilot would allow excipient manufacturers to gain FDA review of certain novel excipients prior to their use in drug formulations. It is intended to foster excipient development that may be useful in scenarios in which excipient makers and drug developers have cited difficulty in using existing excipients. CDER is seeking initial proposals for the pilot through 12/7. To view the notice, click here.