Latest Federal Register Notices
Panel to Discuss GSK NDA for OTC Nicotine Spray
Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotine oral spray for withdrawal symptoms. 08/16/2019
Nonclinical Osteoporosis Drug Study Guide
Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies. 08/16/2019
Info Collection Extension for ‘Dear Doctor’ Letters
Federal Register notice: FDA seeks comments on an information collection extension for the guidance on “dear doctor” letters. 08/16/2019
Info Collection on Device Sterilization Agreements
Federal Register notice: FDA sends to OMB an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150.” 08/15/2019
Info Collections Consolidated for Informed Consent/IRBs
Federal Register notice: FDA seeks comments on an information collection revision for “Protection of Human Subjects; Informed Consent; and Institutional Review Boards (IRB) — 21 CFR Parts 50 and 56.” 08/14/2019
Draft Guide on Gastroparesis Drug Development
Federal Register notice: FDA posts a draft guidance on gastroparesis drug development. 08/14/2019
Guide on Drug Labeling About Child Packaging
Federal Register notice: FDA makes available a final guidance entitled “Child-Resistant Packaging Statements in Drug Product Labeling.” 08/14/2019
Mammography Quality Assurance Advisory Panel Renewal
Federal Register notice: FDA renews the National Mammography Quality Assurance Advisory Committee for an additional two years. 08/13/2019