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To Give Rare Disease Patients Hope, the FDA Must Re-Focus its Efforts

MedCity News

To bring cross-agency clinical leaders together, the FDA should establish a Center of Excellence for Rare Diseases. The post To Give Rare Disease Patients Hope, the FDA Must Re-Focus its Efforts appeared first on MedCity News.

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Dear FDA: WTF?

World of DTC Marketing

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?

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The FDA and Aduhelm: WTF?

World of DTC Marketing

SKIMMERS SUMMARY: Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. government. Natalie Shure, The New Republic.

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Do patients care about accelerated approval drugs?

World of DTC Marketing

Do patients care? Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. Do patients care? Should patients be made aware that the drug they are being prescribed is an “accelerated approval drug”?

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“I don’t trust the FDA anymore”

World of DTC Marketing

SKIMMERS SUMMARY: Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product. Medpage Today.

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The debate on DTC marketing is going to heat up again

World of DTC Marketing

The FDA needs to study what people do when they see a DTC ad. Here are some myths around DTC marketing: 1ne: DTC ads result in patients asking for prescriptions they don’t need. They research the drug online and ask their physician about it if they decide it’s a treatment option. Again this is not true.

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FDA Resolves Semaglutide Shortage: What This Means for GLP-1 Compounding Pharmacies and Telehealth Weight Loss Companies

Nixon Gwilt Law

On February 21, 2025 , the FDA officially determined that the shortage of semaglutide injection products has been resolved. When the FDA determines the drug shortage is resolved, the normal restrictions on compounding will apply once again. Those impacted must navigate critical regulatory changes now in play for compounded semaglutide.

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