Drugs

DAA Guidance Terminology Change Suggested

AbbVie says that an FDA draft guidance on developing direct-acting antiviral (DAA) drugs for treating hepatitis C routinely uses the term “resistance associated substitutions” for the specific viral genome position changes that confer resistance. The company’s comment letter says that the term “resistance associated variants” is commonly used rather than “resistance associated substitutions.” If the agency decides to retain its term, the letter says, it should be added to the guidance’s glossary of acronyms. The company also provides line-by-line specific comments and recommendations.

Merck’s comment letter says it commends FDA for issuing a revised version of the draft and also includes specific line-by-line comments.

The Hepatitis Foundation International also praises FDA for the draft guidance, saying that its recommendations are important for industry to consider when developing DAA drugs to treat hepatitis C. “The idea of having several phase developments that assess different aspects of the drug is extremely important,” the foundation says. “The human safety data collected in Phase 1 is key because it determines if the drug is safe for use in humans and whether the production of the drug should continue. As a patient advocacy group, we fully support treatments that have limited side effects which could impede patients’ quality of life.”

The comment letter also recommends assessment of populations in addition to those listed in the draft during drug development. And it says that factors of age and race should also be considered during the Phase 3 efficacy trial.

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