Drugs

PhRMA Comments on Drug Labeling Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says a revised FDA draft guidance on the content and format of the Dosage and Administration section of labeling for human prescription drug and biological products provides more detail and direction than its previous 2010 document. PhRMA says the revised guidance “will provide useful information for consideration during labeling development for new products and new uses of existing products.”

The trade group says it encourages the agency to acknowledge in the final guidance that certain dosing-related information, including pediatric information, may be included, and even required, in other sections of the labeling.

The PhRMA letter also has specific comments on Organization and Format; Critical Information for the Safe and Effective Use of the Drug; Other Therapy Used Before, During, or After Drug Treatment or Administration; Additional Preparation and Administration Instructions; Storage Instructions for the Reconstituted or Diluted Product; Instructions to Avoid Harm Related to Drug Handling and Administration; and Additional 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