Human Drugs
FDA Accepts KemPharm NDA for ADHD Drug
FDA accepts for review a KemPharm NDA for its investigational product candidate KP415 (serdexmethylphenidate) for treating attention deficit hyperacti...
FDA Postpones Domestic/Foreign Inspections Indefinitely
FDA says it postponing domestic and foreign inspections indefinitely during the Covid-19 emergency.
Human Drugs
Lawmakers Bill on American Drug Independence
Rep. Anna G. Eshoo (D-CA) and Rep. Susan W. Brooks (R-IN) introduce legislation entitled Prescription for American Drug Independence Act that seeks so...
Human Drugs
Updated Guide on Covid-19 Convalescent Plasma
FDA issues an updated guidance on Investigational Covid-19 Convalescent Plasma.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 5/1/2020.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Guide on Nicotine Delivery System Enforcement
Federal Register notice: FDA makes available a final guidance entitled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Othe...
Federal Register
Info Collection on Animal Drugs for Minor Species
Federal Register notice: FDA sends to OMB an information collection extension for Index of Legally Marketed Unapproved New Animal Drugs for Minor Spec...
Medical Devices
Guide on Posterior Cervical Screw Systems
FDA posts a final guidance entitled Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide.
Human Drugs
FDA OKs Janssen Biotechs Subcutaneous Darzalex Faspro
FDA approves a Janssen Biotech BLA for subcutaneous Darzalex Faspro for adult patients with newly diagnosed or relapsed/refractory multiple myeloma.
