Drugs

Drug Instructions for Use Guidance

FDA has published a guidance, Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format, with recommendations for developing the content and format of a patient instructions for use (IFU) document for human prescription drugs and biological products, as well as drug-led or biologic-led combination products, submitted under an NDA or BLA. The document says the IFU is written for patients or their caregivers who use drug products that have complicated or detailed patient-use instructions. “The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products,” it says.

The guidance recommendations do not apply to labeling for standalone devices or device constituent parts of cross-labeled combination products if the device constituent is marketed under a device authorization. The recommendations also do not apply to standalone devices regulated under a BLA, such as devices associated with blood collection and processing procedures.

FDA says the guidance is one of several documents it is issuing to fulfill performance goals under PDUFA 6.

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

Read more

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