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Panel Votes Down OTC Cold Ingredient

[ Price : $8.95]

An FDA advisory committee votes 16 to 0 that current scientific data do not support the effectiveness of the over-the-counter phen...

Mallinckrodt Recalls One-Way Ventilator Valve

[ Price : $8.95]

Mallinckrodt recalls its One-Way Valve, 22F x 22M due to reports about the devices not opening properly, which prevents or reduces...

Jury Convicts 2 for Clinical Trial Fraud

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A Florida federal jury finds two defendants guilty of conspiring to falsify clinical trial data for profit.

OTC Drug User Fee Rates

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Federal Register notice: FDA announces the over-the-counter (OTC) monograph order request fee rates under the OTC monograph drug u...

FDA Permanently Debarring Tatsene

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Federal Register notice: FDA issues an order to permanently debar Mayya Tatsene from providing services in any capacity to a perso...

LimFlow Gains Approval for Leg Ischemia

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FDA approves a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia who have no other s...

45 Device Alerts Issued in 2022: FDA

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FDA issues its first Postmarket Device Safety-Related Communications report to Congress that details 45 safety-related communicati...

Justice Petitions Supreme Court Over Mifeprex

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The Department of Justice petitions the U.S. Supreme Court asking it to reverse last months decision by the Fifth Circuit Court of...

Updated Covid-19 Vaccines Approved by FDA

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FDA gives the green light for updated Covid-19 vaccines manufactured by ModernaTX and Pfizer that are formulated to more closely t...

Tagrisso Phase 3 Data in Lung Cancer

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AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy in lung cancer patients ...