Latest Federal Register Notices
More Product-specific Guidances for ANDAs
2/18/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
Info Collection Extension on CDRH Appeals Processes
2/18/2022 Federal Register notice: FDA is seeking comments on an information collection extension entitled “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The collection supports implementation of recommendations found in FDA’s 2019 Center for Devices and Radiological Health (CDRH) Appeals Processes guidance. To view the notice, click here.
Integrated Continuous Glucose Monitor is Class 2
2/18/2022 Federal Register notice: FDA is classifying the integrated continuous glucose monitoring system into medical device Class 2 (special controls). The action is based on a Dexcom de novo classification request for the Dexcom G6 Continuous Glucose Monitoring System. The agency has identified the device as being intended for use to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. To view the notice, click here.
IND Regulations Information Collection Revision
2/17/2022 Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Investigational New Drug Application Regulations — 21 CFR part 312” (OMB Control Number 0910-0014). The information collection reflects program changes and adjustments. The agency has revised it further to account for burdens that may be incurred by respondents who choose to adopt or implement recommendations discussed in agency guidance documents intended to assist respondents in complying with regulatory requirements in Part 312. To view the notice, click here.
Device QSR Modernization/Harmonization Meeting
2/17/2022 Federal Register notice: FDA has announced a 3/2 Device Good Manufacturing Practice Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the current GMP requirements for medical devices in the Quality System Regulation (21 CFR part 820) and to align it more closely with an international consensus standard (International Organization for Standardization’s 13485:2016). Earlier this month, OMB completed its review of CDRH’s long-awaited proposed rule to modernize and harmonize the Quality System Regulation. To view the notice, click here.
Workshop on Generic Drug Research Initiatives
2/16/2022 Federal Register notice: FDA has announced a 5/9-10 public workshop entitled “FY 2022 Generic Drug Science and Research Initiatives Workshop” that will provide an overview of science and research initiatives for generic drugs and an opportunity for public input on the initiatives. To view the notice, click here.
Drug eSubmission Data Standards Updated
2/15/2022 Federal Register notice: CDER and CBER are announcing that 2/15 is the date that support begins for version 3.1.1 of the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide, and 3/15 is the date that this version update is required in certain electronic submissions. The agency will update its FDA Data Standards Catalog to reflect these changes. To view the notice, click here.
Meeting on FDA Hiring/Retention Report
2/14/2022 Federal Register notice: FDA has announced a 3/15 virtual meeting entitled “FDA Hiring and Retention Final Assessment” and an opportunity for public comments. The meeting is intended to discuss an independent assessment performed by Booz Allen Hamilton. Comments can be submitted until 5/16. To view the notice, click here.