Drugs

Generic Drug Correspondence Guidance Inadequate: AAM

The Association for Accessible Medicines (AAM) says a 12/17/20 FDA final guidance, Controlled Correspondence Related to Generic Drug Development, is informative but “does not adequately cover the process related to development of a generic drug-device combination product.” The association’s comment letter says that, as an example, the guidance does not address how a sponsor can share the design of its device and the proposed device for a generic combination product for evaluation by FDA during the early stages of development.

AAM also says it continues to have concerns with the quality and consistency of FDA responses to submitted controlled correspondence. Specifically, it says, the lack of meaningfulness and accuracy of FDA responses often generate a subsequent submission of a control or, worse, an ANDA submission that is rejected due to inaccurate or misleading agency recommendations provided to an applicant in a controlled correspondence.

The association also expresses concern with the growing number of controlled correspondences that are being submitted for inactive ingredient queries and other issues that contribute to the need for industry to submit controls.

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