Drugs

ANDA Information Request MAPP

The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures, Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications, describing how the Office of Generic Drugs and Office of Pharmaceutical Quality will issue such requests and letters under GDUFA 2 commitments. The MAPP says that under GDUFA 2 the agency initiated a program to act on received ANDAs within agreed times. As part of the effort, FDA started using multiple types of letters about the assessment of an application, including complete response letters, easily correctable deficiencies, and information requests (IRs).

In GDUFA 2, the MAPP says, it was agreed that at about the midpoint of the assessment clock FDA would (1) issue an IR to request clarification or further information that is needed or would be helpful to allow completion of a discipline assessment; and/or (2) issue a discipline review letter to convey preliminary thoughts on possible deficiencies found by a discipline assessor and/or assessment team for its portion of the pending application after a discipline assessment.

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