Drugs

Antibody Impurity Guidance Needs Specificity: Comments

The Association for Accessible Medicines (AAM) says an FDA draft guidance on establishing impurity specifications for antibiotics is very general and lacks specific recommendations for setting thresholds for impurities in the products covered by the guidance. In its comment letter, AAM contrasts the FDA draft with one from the European Medicines Agency (EMA) that it says has more specific guidance on acceptance criteria that includes thresholds for reporting, identification, and qualification for certain categories of active substances.

“As FDA is aware,” the letter says, “many drug development programs are global in nature, and consistency across health regulatory authorities is important to support efficient development of critical medicines that can be made available around the world to patients who need them.”

AAM says some of its members have observed that some FDA reviewers seem to be applying the thresholds in the EMA guideline during their reviews, although FDA has not announced its intention to do so, and other FDA reviewers may be taking a different approach.

“To avoid adverse impacts on products under development associated with changing expectations and inconsistent approaches during reviews, FDA should issue more detailed guidance describing its expectations for establishing thresholds for irregularities in these critical products,” AAM says.

The association also asks for clarification of the agency’s expectations about the application of the principles described in the draft to marketed products, applications under development, and applications currently pending before FDA.

In its comment, the Parenteral Drug Association urges FDA to harmonize the terminology in the guidance with that in the applicable International Council for Harmonization (ICH) guidelines. It says it recommends the use of “drug substance” rather than “active pharmaceutical ingredient” and alignment of the terms “degradation products” and “impurities” to the ICH definitions.

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