Drugs

FDA Finalizes PLAIR Guidance

FDA has published a guidance, Pre-Launch Activities Importation Requests (PLAIR), finalizing a 7/2013 draft guidance with the same name. The document describes agency policy on requests for the importation of unapproved finished drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending NDA or ANDA.

The guidance also applies to unapproved BLAs regulated by CBER, FDA says, and unapproved combination products assigned to CDER for which NDA, ANDA, or BLA approval is anticipated. The guidance further describes the procedure for making requests for the importation of unapproved finished dosage form drug products before final approval of the application and the factors that FDA will consider in granting such requests.

“The guidance adopts most elements of the PLAIR program announced in the 7/2013 draft guidance, updates the information that should be submitted to FDA in a PLAIR, describes when and how a PLAIR can be submitted, and explains the circumstances under which the agency intends to grant a PLAIR,” the document says.

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