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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Do patients care about accelerated approval drugs?

World of DTC Marketing

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. Of course, they should, but in the end, it’s going to come down to trust in their doctor and the FDA. Do patients care? Do patients care?

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FDA accepts resubmission of Ardelyx’s NDA for XPHOZAH

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Leading in Pharma: a woman’s pathway

European Pharmaceutical Review

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). I am a physician by training, and I worked in New York hospital emergency rooms for many years.

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Techsomed Announces FDA Clearance for Ablation Treatment Planning and Confirmation Software

Legacy MEDSearch

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., VisAble.IO “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

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The debate on DTC marketing is going to heat up again

World of DTC Marketing

DTC ads do NOT lead to unnecessary Rxs. The FDA needs to study what people do when they see a DTC ad. They research the drug online and ask their physician about it if they decide it’s a treatment option. 4our: DTC marketing should be illegal because it leads to unnecessary Rx’s. Again this is not true.

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FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.