United States

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

NAD and NARB track their decisions on support for ad claims with Federal Trade Commission policies, including the requirement of RCTs to support health claims for supplements, a standard the industry argues is required for drug claims and shouldn’t be applied for dietary ingredients.

During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.

After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.

CHPA Health In Hand Foundation accepting nominations for 2025 US Self-Care Marketing Awards; Celsius hires former PepsiCo as president/COO and closes $1.8bn acquisition of energy drink competitor Alani; and AdvoCare adds John Peirano as integrated marketing VP after hiring Kathy Blosser supply chain VP.

After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.