Drugs

AAM Comments on Controlled Correspondence

The Association for Accessible Medicines (AAM) says it applauds FDA for taking a bold step in developing a guidance on quality-related controlled correspondence “to mitigate duplicative work for both the industry and the agency.” FDA defines a controlled correspondence as a correspondence submitted to the agency by a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or certain post-approval submission requirements.

The association’s 11/19 comment letter says the ability to bypass submitting a controlled correspondence for some types of duplicative questions will speed up and minimize delays in development of ANDAs for applicants.

Likewise, AAM says, with less and less duplicative controlled correspondence being submitted, FDA will be better able to focus its limited resources to other areas of need.

The letter encourages FDA to build upon the contents of the guidance by routinely reviewing and assessing the controlled correspondences received to add to the existing content for continuous improvement to the controlled correspondence process.

The letter includes general and technical comments for agency review and consideration.

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