Caris Life Sciences submits PMA applications for two whole transcriptome sequencing precision medicine assays.
FDA warns Professional Compounding Pharmacy about compounding regulation and CGMP violations in its production of compounded human and animal drugs.
FDA publishes a guidance explaining how the medical device eCopy Program will work as required by the FDA Safety and Innovation Act.
FDA issues conservation strategies for a range of circumstances involving personal protective equipment used by healthcare providers.
FDA releases its latest batch of Warning Letters that includes one medical product company Health Solutions Pharmacy.
FDA grants Takeda Pharmaceutical a breakthrough therapy designation for mobocertinib for treating patients with metastatic non-small cell lung cancer ...
FDA discusses potential challenges to bioequivalence studies being conducted for submission with ANDAs during the Covid-19 pandemic.
FDA says its flexibility during the pandemic has led to over 1,500 additional firms registering to produce hand sanitizer.