Drugs

FDA Again Delays Non-Rx Drug Final Rule

As part of the Trump Administration’s regulatory freeze while it reviews pending FDA actions, the effective date of a recent final rule entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use (ACNU)” is delayed from 3/21 to 5/27. Previously, the rule was delayed for the same reason from 1/27 to 3/21.

The final rule establishes requirements for a nonprescription drug product with an ACNU, including application, labeling, and postmarketing reporting requirements, according to an FDA notice. In addition to applicable existing application requirements, the final rule also establishes the specific requirements for an NDA or ANDA with an ACNU.

The rule also clarifies that an ACNU “constitutes a meaningful difference between a prescription drug product and a nonprescription drug product that makes the nonprescription drug product safe and effective for use without the supervision of a practitioner licensed by law to administer such drug; therefore, a prescription drug product and a nonprescription drug product with an ACNU with the same active ingredient may be simultaneously marketed even if they do not have meaningful differences other than the ACNU, such as different indications or strengths,” according to the agency.

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