A CBER notice of violation says Sparrow Health & Performance is providing unapproved adipose tissue-derived cellular products to treat many diseases a...
FDA says it has updated the question-and-answer appendix in its guidance on conducting medical product clinical trials during the public health emerge...
CDER outlines recommendations for drug sponsors seeking product development inquiries for Covid-19 products.
FDA grants Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19.
FDA releases an FDA-483 with nine observations from an inspection at Nephron Sterile Compounding Center.
The DC Circuit Court of Appeals says FDA acted properly in denying a PMRS NDA for an opioid product that claimed abuse-deterrent properties and reject...
FDA says an Applied Medical recall of three embolectomy and cleaning catheters is Class 1.
PhRMA says it generally supports the FDA capacity planning adjustment methodology for drug and biologic user fee programs.