• Device Groups Say FDA Communication Guidance Gets Additional Information Letters Wrong

    Several entities within the medical device industry are calling attention to a provision within a recent draft guidance published by the US Food and Drug Administration (FDA) that they say offers little in the way of clarification and could potentially be a sticking point during complicated and contested review proceedings. Background In March 2013, FDA released a long-awaited guidance entitled Types of Communication During the Review of Medical Device Submissions . T...
  • Health Canada Announces Adoption of New GMP Standards for Active Ingredients

    Canadian public health officials have announced the expansion of Health Canada's regulatory authority to inspect and require all active ingredients(AIs)-sometimes referred to as active pharmaceutical ingredients (APIs)-to meet current good manufacturing practice (CGMP) standards. The change in some ways reflects a change in the way pharmaceutical products are now manufactured. Many facilities will manufacture just AIs or APIs, sending the finished product to a second man...