Dr. Reddys Laboratories recalls four lots of phytonadione injectable emulsion, 10 mg/mL single-dose ampules due to the potential for ampules to break ...
FDA releases a guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.
FDA releases a guidance entitled Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.
FDA sends Warning Letter to Carahealth (Galway, Ireland) objecting to herbal products being offered online for treating Covid-19 patients.
Federal Register notice: FDA cancels a 5/15 Advisory Committee meeting due to outstanding review issues related to the safety and efficacy of DBV Tech...
Federal Register notice: FDA modifies the list of standards it recognizes for use in medical device premarket reviews.
FDA posts Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the Covid-19 Pandemic.