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.
Companies blazing a path in the biosimilars arena likely have a long wait before their products can achieve an interchangeability designation, as the FDA admits to slow progress on that standard. And even after the standard is set, brand companies may have the only chance at getting an interchangeable designation, Jonathan Loeb, a partner at Dechert, said. Instead of developing products from scratch, they could create interchangeable versions of their own approved biologics, similar to how brand drugmakers create authorized generics. Washington Drug Letter