Drugs

FDA Proposes 1-Page Patient Medication Information

FDA is proposing to amend its Medication Guide regulation to require applicants to create a new one-page Patient Medication Information (PMI) for prescription drug products. A Federal Register notice says the PMI would have a standardized format and content that would be submitted to the agency for approval.

The notice says the current written information given to patients can be duplicative, incomplete, conflicting, or difficult to read and understand, and has not been sufficient to meet the needs of patients. “PMI is intended to improve public health by providing patients with clear, concise, accessible and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively,” it says.

Under the proposed rule, PMI would highlight essential information that the patient needs to know about the prescription drug and basic directions for using the product: drug name, important safety information, common side effects, and directions for use.

FDA is proposing a five-year implementation for PMI and says it would withdraw the current regulations requiring Medication Guides for certain prescription drugs after all products that currently have Medication Guides have FDA-approved PMI. During the implementation period, it says, the current Medication Guide regulations would remain in place but would not apply to a prescription drug once it has an approved PMI.

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