Drugs

Comments on Good ANDA Submission Practices

The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) says it welcomes issuance of an FDA draft guidance to assist ANDA applicants by highlighting common, recurring deficiencies in ANDAs and to provide recommendations on how to avoid these and other similar deficiencies with the goal of minimizing the number of review cycles to approval. The association comment says the draft guidance “offers opportunity for additional clarity regarding FDA’s expectations related to patents and exclusivity, labeling, product quality, and bioequivalence deficiencies.” The association lists several areas in the draft that need further clarification.

The International Pharmaceutical Excipients Council of the Americas says its members have some concerns on the need for a better understanding of expectations for atypical actives covered in the draft. It says it has asked the United States Pharmacopeia to establish an expert panel on atypical actives. FDA would be invited to participate on the panel once it is established, it says.

In its letter, Perrigo asks that FDA in the final guidance tabulate all guidance documents considered applicable to ANDAs and cross reference them by number as applicable throughout this guidance. It also says it would be helpful to have a keyword tag or organization system to allow sponsors to more readily identify which guidance documents are applicable to their specific product.

Specific line-by-line comments were provided by these three organizations as well as Apotex and Sanofi.

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