Drugs

Groups Want Changes in Drug Labeling Guidance

The Association for Accessible Medicines (AAM) says an FDA draft guidance on the content and format of composition statement and corresponding statement of ingredients in NDA and ANDA labeling “can help speed ANDA reviews.” The association’s comment letter says clear and complete statements of ingredients in NDAs can assist ANDA applicants in developing generic drugs that meet all applicable requirements. “Providing FDA’s expectations regarding composition statements in ANDAs and labeling helps ANDA applicants prepare high quality applications and can help speed FDA reviews,” AAM says.

It also says a similar guidance would be appropriate for biologic reference products and biosimilars. It provides several text-specific comments as well.

In its letter, Pharmaceutical Research and Manufacturers of America asks the agency to clarify the scope of recommended and required information about inactive ingredients. It also recommends that the draft guidance be revised to acknowledge that FDA cannot disclose proprietary information about inactive ingredients.

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

Read more

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