Drugs

MAPP on NDA/BLA Financial Disclosure

CDER has issued a Manual of Policies and Procedures (MAPP) establishing policies and procedures for review staff in the Office of New Drugs for the review and management of financial disclosure information submitted in NDAs and BLAs and supplements to them. A 1998 final rule “is intended to ensure that financial interests and arrangements of clinical investigators or sub-investigators that could affect the reliability of data submitted to FDA are identified and disclosed by the applicant,” the MAPP says.

Under the policy, the Office of New Drugs will encourage sponsors to work with the review team and clinical investigators to ensure that potentially covered clinical studies are sufficiently well designed and conducted to minimize potential bias should financial arrangements of clinical investigators or sub-investigators subsequently be identified. “If a sponsor informs FDA of such financial interests or arrangements,” the MAPP says, “these will be identified as agenda items for discussion at end-of-Phase 2, pre-IND, and pre-NDA meetings, if appropriate.”

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