Drugs

Stakeholders Suggest Drug-Device Product Guidance Changes

The Combination Products Coalition says that while it agrees with many of the recommendations in an FDA draft guidance on comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, it believes there should be several revisions. The coalition says it strongly recommends that FDA revise the document to:

improve alignment between the draft guidance and existing human factors guidance provided by FDA and by recognized U.S. and international standards;
focus comparative analyses on risk, not use error rates;
describe human factor studies as qualitative research (to assess the adequacy of the product user interface) rather than quantitative research (to assess the user’s capabilities);
promote innovation and improvements in product design to enhance safety and effectiveness; and
provide more detailed information on topics not sufficiently addressed in the draft.

AdvaMed’s comment letter raises a concern that the draft guidance proposes an approach that is inconsistent with CDRH 2/3/16 guidance on applying human factors and usability engineering to medical devices and does not appropriately factor in risk-based approaches. “This draft guidance frequently discusses methods that are similar, but meaningfully different,” the letter says. “Modest changes to the language and suggested study designs in this draft guidance could enable the methodology to be aligned with other FDA human factor guidances and recognized standards, while also ensuring the generic product is interchangeable with the reference from a usability perspective and safe for users.”

Specific comments were submitted by the Chartered Institute of Ergonomics and Human Factors and Sanofi.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

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