Drugs

Concerns Raised with FDA Priority Submissions Guidance

The Association for Accessible Medicines (AAM) says that a draft FDA guidance on “Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Associated with Priority Submissions,” represents a fundamental departure from the GDUFA 2 comment letter and may unintentionally discourage ANDA sponsors from submitting a priority review request. In its comment letter, AAM says that as written, the draft “is not in the best interest of the public health and defeats the mission and goal of the new commissioner to increase access to affordable generic medicines in a timelier manner.”

The letter says that ANDA sponsors will forego submission of priority review requests due to the fact that FDA has placed a huge hurdle in front of industry with the requirement in the guidance that facility information (pre-submission facility correspondence or PFC) be submitted in advance of the actual ANDA. “The sole purpose of the PFC was to provide advance notice, enabling FDA to better anticipate and coordinate its resources to meet the GDUFA 2 commitment for priority review,” the letter says.

AAM also submits line-by-line comments, as do Apotex and Perrigo.

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