Drugs

2 ANDA Review Documents Coming: Consultants

FDA hopes to issue by the end of the year a Good ANDA Assessment Manual of Practices and Procedures and a Good ANDA Review Practices document, according to information gathered by Lachman Consultants at a recent Waxman-Hatch meeting with commissioner Scott Gottlieb. In an online post, the consulting firm says the two documents “could go a long way towards standardizing the process and further putting forth FDA expectations regarding both the filing (receipt) of an ANDA and the review content of an ANDA.”

The post outlines concerns it says industry has had about FDA asking for items out of the blue, such as things that have not been asked of an applicant before or things that may be nice to know but are not necessarily essential to approval as outlined in existing guidance or past agency expectations. “These kinds of questions drive the industry nuts,” Lachman says, “especially when they have had other ANDAs approved without those questions being asked.”

The firm concludes that “there is still lots of work to be done on both FDA’s and industry’s side to resolve and improve the ANDA submission and review process. Let’s hope this is a step in the right direction. It would be interesting to know what FDA thinks of this issue in terms of how to improve the situation.”

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