Drugs

Final Guide on Oncology Radiopharm. Drug Studies

FDA has published a final guidance, Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations, to give sponsors information on the design of an appropriate nonclinical program for developing radiopharmaceuticals to treat cancer, also known as oncology therapeutic radiopharmaceuticals. The document also contains recommendations for certain aspects of product labeling.

The guidance is specific to therapeutic radiopharmaceuticals for oncology indications and covers topics not addressed in current FDA or International Council for Harmonization guidances, such as nonclinical studies in support of first-in-human trials and approval. It provides additional information that supplements an 11/2011 guidance on the design of late radiation toxicity studies.

The guidance recommendations generally apply to new products with no previous clinical experience. Concepts discussed are evaluation of toxicities from the ligand, evaluation of radiation toxicities, and information for product labeling as related to reproductive toxicity, genotoxicity, carcinogenicity, contraception, and use in lactating women.

Contents are Introduction, Background, Pharmacology, Animal Biodistribution and Dosimetry, Toxicology, First-in-Human Dose Selection, Labeling Recommendations, Glossary, and References.

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