Drugs

Year-One Report on the Generic Drug Cluster

FDA and the other regulatory agencies that are members of the Generic Drug Cluster have spent their inaugural year in meetings in which they collaborated on several regulatory topics. In an online CDER Conversation, Office of Generic Drugs (OGD) associate director for global generic drug affairs Sarah Ibrahim says many of the topics Cluster members addressed focused on comparing and evaluating regulatory approaches, identifying similarities, and assessing differences.

Ibrahim defines the Cluster as a forum that provides OGD and FDA access to information from partner regulatory agencies including the European Medicines Agency, Health Canada, the UK Medicines and Healthcare products Regulatory Agency, Swissmedic, and the Israeli Ministry of Health. She says the Cluster “offers a confidential forum for the world’s leading regulatory agencies to develop a common understanding of each agency’s regulatory requirements for approval as well as their current thinking on topics related to generic drug development. The Cluster is unique among international generic drug discussion groups in that it focuses on early communication to establish alignment on scientific perspectives where possible.”

Cluster parties have reached an agreement on gathering and assessing data from participating agencies concerning both an oncology treatment and bioequivalence for a mental health treatment. They also agreed to share data on human testing of certain drugs for which different testing populations are used, such as patients versus healthy volunteers. And they are establishing a process for sharing data integrity concerns about bioequivalence and pharmacokinetic data.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome