Drugs

CDER Revises ANDA Review Internal Policy

CDER has revised a Manual of Policies and Procedures (MAPP 5700.1, Rev.1) entitled “ANDA Amendments and Supplements Reviewed by the Division of Filing Review.” The document outlines policies and procedures for the Center to determine whether an amendment or supplement should be reviewed by OGD’s Division of Filing Review (DFR). The MAPP was revised to include a new work guide related to prior approval supplements and provide minor clarifications and formatting corrections. Specifically, DFR evaluates an amendment to an ANDA or a prior approval supplement if the submission contains the following changes:

Adding a new strength
Changing the formulation
Prescription to over-the-counter switch
Changing the container closure system for parenterals
Reintroducing or reactivating a strength that has been discontinued or not marketed in several years

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