Drugs

PDUFA 7 Reauthorization Meeting Notes

FDA has released notes from three workgroup and subgroup meetings as part of PDUFA 7 reauthorization discussions between the agency and industry representatives:

Manufacturing and Inspections Workgroup, 11/18/20. The meeting focused on finalizing discussions at the subgroup level for industry proposals relating to pre-approval/pre-licensure inspections waivers, application content versus inspection content, and announced pre-approval/pre-licensure inspections.
Postmarket Subgroup, 12/2/20. The meeting discussed REMS assessments and explored possible options for increasing the review process efficiency, including adjusting the time interval for REMS assessments. FDA agreed to take questions on timing and process to agency REMS experts. The participants also discussed FDA’s proposal on Sentinel and pregnancy safety. There also was a brief discussion of the use of Sentinel analytics and health outcomes of interest.
Postmarket Subgroup, 12/9/20. The session had a more detailed discussion of FDA’s REMS assessment proposal and its Sentinel proposal, including the possibility of Sentinel demonstration projects using analytics and the pregnancy safety project. The parties agreed that the subgroup is making good progress. FDA and industry have both shared their proposals, including resource estimates. Members expressed satisfaction that the discussions were focusing on specific aspects of the proposals and specific resource needs.

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

Read more

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