Drugs

Gottlieb Wants More Transparency with Complete Response Letters

FDA commissioner Scott Gottlieb says he would like to make redacted complete response letters publicly available. Patient groups and certain other stakeholders have been asking the agency for years for more information when the agency rejects an NDA or BLA. And now-retired CDER Office of New Drugs director John Jenkins frequently hinted he was an advocate of releasing complete response letters, but it always seemed to get hung up due to confidentiality concerns.

Gottlieb told BioCentury 6/23 that he is in favor of making complete response letters public after scrubbing them of proprietary data, and tweaking policies to make it easier for biosimilars to obtain interchangeability designations. Another priority, Gottlieb said, is making sure agency policies do not prevent drug companies and payers from having the conversations needed to negotiate outcomes-based reimbursement agreements. And like every other FDA commissioner, Gottlieb said he is considering a reorganization of some FDA Centers. “Deliberations about the agency’s structure are leaning toward greater vertical integration, for example by establishing centers of excellence to combine expertise in certain clinical areas from the agency’s Centers for drugs, biologics and devices,” BioCentury reported.

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

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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