Federal Register
Guide on Animal Drug In-use Stability Studies
Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements f...
Human Drugs
Evaluating Gastric pH-Dependent Drug Interaction Guidance
FDA makes available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, a...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 11/27/2020.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Guide on Drug Development Qualification Tools
Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.
Federal Register
Guide on Complex ANDA Product Meetings
Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA...
Medical Devices
Notifying CDRH About Device Shortage Guidance Update
FDA updates a CDRH Covid-19 guidance on notifying the agency of medical device discontinuance or shortages.
Medical Devices
Use 510(k) for OTC Hearing Aids: Authors
Two hospital-based doctors call on FDA to clear OTC hearing aids using the 510(k) pathway.
Medical Devices
CorticoMetrics AI-based Software Cleared for Radiologists
FDA clears a CorticoMetrics 510(k) for Thinq, its artificial intelligence-based software for use by radiologists and neurologists to provide quantitat...
Human Drugs
Eiger Bio NDA for Rare Preemature Aging Disease
FDA approves an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Hutchinson-Gilford Progeria Syndrome and processing-deficient Proge...
