Drugs

Comments on Liquid Drug Flow Restrictor Guidance

The Consumer Healthcare Products Association (CHPA) says an FDA draft guidance on flow restrictors for oral liquid drug products “reflects recommendations by the agency for which CHPA members are supportive for the most part.” The association’s comment letter includes input on the Directions for Use section of the guidance and general recommendations.

In its response, Johnson & Johnson says it has partnered with CHPA through its review and commenting process and supports the comments that association submitted. However, the company also provides its comments about the scope of the guidance, alignment with other regulations, toxicology assessment, use of graphical images on labeling insert, and data for labeling comprehension. It also included specific line-by-line comments.

The Combination Products Coalition asks that FDA further clarify the designation of restricted delivery systems, including whether they are considered to be medical devices. It also wants the draft guidance to include considerations and recommendations for using restricted delivery systems, but not give requirements for their use since guidances do not establish legally enforceable responsibilities.

Novartis provided line-by-line specific comments.

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