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.
Medicis Pharmaceutical has received notice that Barr Laboratories has filed an ANDA to market a generic version of Medicis’ once-daily, oral acne treatment Solodyn — a drug that is the subject of a citizen petition. Barr’s application includes a Paragraph IV certification on the ’838 patent that covers Solodyn (minocycline HCl) extended-release tablets in 45-, 90- and 135-mg strengths and expires in 2018, according to a Medicis SEC filing. Generic Line