Medical Devices
Warning on Genetic Prenatal Screening Tests
FDA issues a warning about the risks of false results with genetic non-invasive prenatal screening tests.
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 5/20/2022.
Human Drugs
Product Approval Summaries
FDA Webview posts product approval summaries for the week ending 5/20/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Bill Would Whittle Down Biologic Exclusivity
Congresswoman Jan Schakowsky (D-IL) and congressman Bruce Westerman (R-AR) reintroduce the bipartisan Price Relief, Innovation, and Competition for Es...
Human Drugs
Partial Clinical Hold on Leukemia Therapy
FDA issues a partial clinical hold on a Foghorn Therapeutics Phase 1 dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leuk...
Human Drugs
FDA Withdraws 21 No-longer-marketed ANDAs
Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the products were no longer m...
Federal Register
More Product-specific Bioequivalence Guides
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances.
Federal Register
Guide on New Dietary Ingredient Notifications
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subjec...
Medical Devices
Device Cybersecurity Clarifications in FDA Webinar
FDA announces a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled Cybersecurity in Medical Devices: Qual...
