Drugs

Comments on Drug Quality Consensus Standards Guidance

The Combination Products Coalition says it would like FDA to confirm that the scope of the agency’s draft guidance on recognition of voluntary consensus standards related to pharmaceutical quality includes combination products under CDER jurisdiction. In its comment letter, the coalition also asks FDA to clarify (1) how the proposed CDER program will align with the CDRH standards and conformity assessment program for the device constituents of combination products under CDER jurisdiction; (2) how the informal nature of the CDER program will ensure predictability and consistency across CDER for the same device constituent and the same standard; and (3) the type of standards that are expected to be a part of the CDRH program.

In its comment, ASTM International says it supports the goals and concepts outlined in the guidance and the CDER program “to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality.” It also encourages a more structured agency participation in development of standards where appropriate. ASTM also says it would welcome clarity on the process for submission of proposed voluntary consensus standards to CDER and their review, and makes other recommendations.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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