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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

FDA Law

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This blogger is curious to see what else OPDP has up its sleeve for 2023. But a Warning Letter?

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An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He left without it.

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What RFK Jr. Isn’t Talking About: How To Make Vaccines Safer

Physician's Weekly

A little-publicized CDC-led 2022 study suggested that the aluminum salts added to make some pediatric vaccines more effective might cumulatively be linked to an increased incidence of asthma. ” Nath published an article in 2023 calling for more investigation of vaccine-related neurological conditions. The post What RFK Jr.