Drugs

FDA Issues 63 Product-Specific Guidances for Generics

FDA has issued 22 new and 41 revised product-specific guidances that when finalized will describe the agency’s thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. The agency says that since 2007 it has issued more than 1,600 product-specific guidances.

Of the guidances issued, FDA says, four are new draft guidances and 31 are revised guidances for complex drug products, including 23 products that to date do not have generic competition. The majority of the revised guidances were updated to include information on data standards formatting for clinical endpoint bioequivalence studies to align with Clinical Interchange Standards Consortium standards.

The agency says it believes that increased transparency on product-specific guidances gives manufacturers seeking to develop generic copies of medicines, including complex drugs, a better opportunity to efficiently allocate drug development resources.

FDA commissioner Scott Gottlieb says the product-specific guidances “will increase patient access to high-quality, safe, and affordable medicines.”

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