Drugs

Transcript Posted on FDA Hatch-Waxman Amendments

FDA has posted a transcript of a 7/19 public meeting on Hatch-Waxman Amendments and its discussion on whether an appropriate balance is still maintained between brand and generic companies since the law was enacted in 1984. At the meeting, FDA commissioner Scott Gottlieb outlined new approaches the agency will implement to help speed up generic drug reviews and approvals.

By the end of the year, Gottlieb said the agency will issue two key documents to streamline the ANDA review program. First, a “Good ANDA Assessment Practices” policy will “outline ways that we intend to streamline the ANDA review process inside FDA by, among other things, eliminating unnecessary, duplicative procedures and greatly increasing the efficiency of our review,” he said. It will build on the knowledge gained from the user fee program — for example, the practice of “truncating” reviews prevents applicants from fixing their submissions and getting them approved. “The result is additional review cycles, not faster approval,” he said.

The second document will aim to improve submission quality. “It will set forth common, recurring deficiencies that we see in applications, and provide advice on how these problems can be avoided in the first place, so applicants can send us ANDAs that are ‘right the first time,’” Gottlieb told the meeting.

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