Agency IQ

JULY 12, 2024

In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4 for medical devices as “the objective intent of the persons legally responsible for the labeling of” drugs of devices. For drug products, the FDA regulates both product labeling ( 21 CFR 201 ) and promotional labeling ( 21 CFR 202 ).

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The Pharma Data

MAY 15, 2021

Second surprise was that there are drug treatments for osteoporosis – as we might expect – but they’re long-term, unreliable and riddled with side-effects. Yet it turns out that, for some people, the side-effects of some drug treatments were worse than the pain. And it wasn’t pharmaceutical drugs that caused it. Simple as that.

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The Pharma Data

JUNE 18, 2021

Patients who did not meet the definition of confirmed uMRD were randomized 1:1 to receive open-label treatment with ibrutinib or continued ibrutinib + venetoclax. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.

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The Pharma Data

MAY 14, 2021

All the scientific studies… And the words straight from a doctor’s mouth… So you’ll have everything you need… By the way, my name is Matt Stirling. But what scientists and doctors are finally starting to realize… Is if you want to get the fat out of your cells…. Leading to a bigger stomach….

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The Pharma Data

DECEMBER 15, 2020

Food and Drug Administration released a data review that almost guarantees a second vaccine will soon join the Pfizer vaccine that was sent out on Monday: Moderna’s two-shot regimen, which is based on the same technology as the Pfizer vaccine, was found to be 94 percent effective in a clinical trial and carried no serious safety concerns.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration said Thursday night that it will move quickly to authorize the emergency use of Moderna’s coronavirus vaccine after one of its advisory panels voted to give its blessing to the shot. Doctors say this reflects India’s younger and leaner population. FRIDAY, Dec. ” Earlier this week, Gen.

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The Pharma Data

DECEMBER 19, 2020

Food and Drug Administration on Friday, and it will now join Pfizer’s vaccine in an unprecedented national campaign to inoculate enough Americans to stem the spread of COVID-19. Residents of nursing homes, who have suffered a disproportionate share of COVID-19 deaths, will begin to get shots next week, the Times reported.

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