Drugs

OTC Monograph Reform Explained

The Food and Drug Law Institute (FDLI) says over-the-counter drug monograph reforms included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act give FDA additional resources and make the monograph system more nimble, transparent, certain, and conducive to innovation. In an online article, FDLI says the added flexibility and updates to the monograph framework will benefit consumers by protecting public health and increasing self-care choices.

FDLI says the new law “will reach far beyond the OTC market and benefit the entirety of the healthcare system…. The implementation of this law will only further support and encourage the creation of new uses for OTC ingredients and dosage forms, resulting in the expansion and availability of consumer healthcare products.”

The article says the essence of the changes can be described as (1) the notice-and-comment rulemaking process of the OTC monograph system now shifts to an administrative order system within FDA and (2) the law expands FDA resources to work on monograph-related issues through a user fee program authorized for five years.

The article gives more detailed explanations of some of the provisions.

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