Drugs

Changes Urged in ANDA Amendments Appendix

The Association for Accessible Medicines (AAM) says FDA should change the 2018 ANDA Amendments guidance and its Appendix A to conform to changes included in the recent GDUFA 3 commitment letter. “In reevaluating each item in Appendix A,” the association says in a comment letter, “we encourage FDA to consider if a specific deficiency can be resolved through a mechanism or communication other than a major complete response letter. AAM members maintain that many examples exist for which the answer is yes….”

The letter includes a lengthy chart of specific comments and recommendations.

In its response, Apotex says it would be beneficial to both the agency and applicants if FDA would consider resolving deficiencies initially via information request or discipline review letters where applicable. “This approach would align with the GDUFA 3 objective to ‘promote the efficiency and effectiveness of the review process …, increase the overall rate of approval, and facilitate greater access to generic drug products.” Apotex says.

The Teva comment letter says that revisiting Appendix A was an important item of discussion during the GDUFA 3 negotiations. It praises the agency for soliciting public feedback on possible changes rather than committing to specific changes. Teva says it is critical that FDA classify deficiencies as major only when truly warranted, that is, when the deficiency cannot be resolved through another mechanism and the additional review time is necessary to assure the safety and efficacy of the drug. The company also references the AAM chart of specific comments and says it agrees with all of them.

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