Drugs

ANDA Oligonucleotide Guides Needed: AAM

The Association for Accessible Medicines (AAM) says FDA should publish guidance for oligonucleotide product development for ANDAs, particularly for topics not included in product-specific guidances such as recommendations for immunogenicity and inflammation risk assessments and for demonstration of comparability of impurities. The request is included in AAM’s comments on an FDA draft guidance on nonclinical safety assessment of oligonucleotide-based therapeutics.

AAM says the guidances it seeks “would support early product development decisions for generic oligonucleotide products,” noting that its members have experienced challenges in obtaining clarity on the agency’s expectations for immunogenicity for peptides and would like to avoid such issues for the oligonucleotide class of drug products.

AAM also recommends that FDA:

be forward-looking and consider recommendations for follow-on oligonucleotides developed with a drug substance of recombinant DNA origin;
accept nonclinical immunogenicity assessments for such products; and
harmonize with the European Medicines Agency on guidance on these topics to facilitate global product development and timely access for U.S. patients to affordable lower-cost generic products.

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