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Markey and Manchin urge FDA to stop its study of opioids for chronic pain


warned FDA Commissioner Robert Califf against using the method in the agency’s ongoing work to evaluate whether opioids, despite their widespread use, are effective at treating chronic pain. In a letter shared with STAT, Sens. Ed Markey (D-Mass.) and Joe Manchin (D-W.Va.)

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STAT+: FDA panel votes against GLP-1 therapy from former diabetes unicorn Intarcia


An advisory panel to the Food and Drug Administration unanimously voted against a diabetes implant from Intarcia Therapeutics — a former biotech unicorn that faltered after the FDA rejected said implant not once, but twice. FDA then granted Intarcia’s request.

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FDA Authorizes Updated COVID-19 Vaccine Formulations for Current Variants

Pharmacy Times

FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.

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Inside the FDA's Form 483 findings at Novo Nordisk's North Carolina semaglutide plant

Fierce Pharma

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality (..)

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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STAT+: FDA proposes changes to key approval pathway for medical devices, five years after promising


Most medical device companies do not have to test their products on people in order to secure clearance from the FDA — they simply have to show they’re “substantially equivalent” to devices already on the market, called “predicates.” Continue to STAT+ to read the full story…

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FDA Gives 510(k) Clearance to COVID-19, Influenza A/B, RSV Combination Test

Drug Topics

A 510(k) clearance, or a Premarket Notification, requires device manufacturers to notify the FDA at least 90 days ahead of registration with their intent to market a medical device.

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