OTC Drugs

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.

FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad and Commissioner Martin Makary get along?

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

Approval of numerous Rx formulations hasn’t translated to wider availability when a remedy is needed for anaphylaxis emergency, say FDA and the Margolis Institute in announcing workshop on reducing anaphylaxis-related morbidity and mortality.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

Dental guards already accounted for “well over half of the brand’s revenue” and DenTek claimed more than 50% of US category share when PCH launched "Fantasy Guards" campaign targeting fantasy football league enthusiasts.