The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA issued a complete response letter to Evoke Pharma for its Gimoti (metoclopramide) nasal spray for treatment of diabetic gastroparesis, a condition that delays emptying of the stomach. Read More
The FDA revoked its breakthrough therapy designation for Tonix’s posttraumatic stress disorder drug Tonmya (cyclobenzaprine HCl sublingual tablets), citing disappointing interim data from a clinical trial. Read More
The agency has also granted a priority review for Celgene’s supplemental NDA for R2 for the treatment of patients with previously treated follicular and marginal zone lymphoma. The FDA decision date for R2 is June 27, 2019. Read More