Drugs

Draft Unit-Dose Expiration Dating Guidance

FDA has published a draft guidance, Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products, describing the conditions under which the agency does not intend to take action regarding required stability studies and expiration dates for repackaged unit-dose solid oral dosage form drug products. The document addresses repackaging of prescription and over-the-counter solid oral dosage form drugs into unit-dose containers by commercial pharmaceutical repackaging firms that are required to register with FDA and to comply with current good manufacturing practice regulations.

According to the guidance, FDA does not intend to take action if the covered products are assigned an expiration date that does not exceed (1) six months from the date of repackaging, or (2) 25% of the time between the date of repackaging and the expiration date on the container of the original manufacturer’s product, whichever time period is shorter, and if five specified conditions are met. And FDA will not act against products with longer expiration dates if additional specified conditions are met.

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