Latest Federal Register Notices
Comment Period Reopened on Metered Dose Inhaler Guide
Federal Register notice: FDA reopens the comment period for its “Metered Dose Inhaler and Dry Powder Inhaler Drug Products — Quality Considerations; Draft Guidance for Industry.” 10/30/2020
Comment Period Extended on E-Data Files guide
Federal Register notice: FDA extends the comment period until 12/18 for a guidance entitled “Documenting Electronic Data Files and Statistical Analysis Programs.” 10/30/2020
Comments Sought on Drug Labeling Info Collection
Federal Register notice: FDA seeks comments on an information collection extension for “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” 10/29/2020
Guide on Biosimilar Prescribing Information
Federal Register notice: FDA makes available a final guidance entitled “Labeling for Biosimilar Products.” 10/28/2020
Draft Guide on E-Heath Record Data in Clinical Trials
Federal Register notice: FDA makes available a draft guidance entitled “Use of Electronic Health Record (EHR) Data in Clinical Investigations.” 10/28/2020
Draft Guide on Metal Expandable Biliary Stents
Federal Register notice: FDA makes available a draft guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions.” 10/27/2020