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About 1162 results for "us food and drugs administration"

Aurobindo Pharma gets USFDA nod for two drugs

Glenmark receives tentative US FDA approval for generic Epiduo...

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (FDA) for adapalene and benzoyl peroxide gel, 0.1%|2.5%, the generic version of Epiduo gel of Galderma Laboratories ... PharmaBiz, 3 days ago

FDA Sued for Not Disclosing More Info on the Experts Determining the Fate of Drugs and Devices

In a bid to learn more about the experts who advise the US Food and Drug Administration, a consumer advocacy group has gone to court to force the agency to disclose more information about the people whose opinions help determine the fate of numerous ...
 BioSpace3 days ago

Quest Diagnostics' Zika RT-PCR test receives US FDA emergency use authorization

Quest Diagnostics, the world's leading provider of diagnostic information services, has received a US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).
 PharmaBiz2 days ago Quest Diagnostics says its Zika virus test gets US approval  CNBC3 days ago Zika virus test gets U.S. approval  Japan Times3 days ago UPDATE 1-Quest Diagnostics says its Zika virus test gets U.S. approval  Reuters UK3 days ago

US FDA grants breakthrough therapy designations for Novartis' Ilaris to treat rare types of periodic fever syndromes

The US Food and Drug Administration (FDA) has granted three Breakthrough Therapy Designations for Novartis' Ilaris (canakinumab) to treat three rare types of periodic fever syndromes, also known as hereditary periodic fevers. This means Novartis ...
 PharmaBiz4 days ago US Breakthrough designations granted for Novartis Ilaris for rare periodic fever syndromes  Pharma Letter4 days ago Novartis Ilaris gets US FDA breakthrough therapy designation to treat fever syndromes  Pharmafile5 days ago FDA gives ocrelizumab breakthrough designation for PPMS: Roche  Reuters2 months ago

Panic signals in India as USFDA asks drug companies to repeat Semler's studies

MUMBAI|NEW DELHI: A note from the US Food and Drug Administration (FDA) informing drug companies last week about data integrity concerns at Semler Research has sent panic signals across the Indian pharmaceutical industry. The US agency had called ...
 Economic Times1 week ago FDA warns Semler over research data  The Hindu1 week ago US Food and Drug Administration issues data integrity notice to Indian CRO Semler  Economic Times1 week ago
Food Safety Magazine

FDA issues final food-safety rule

The U.S. Food and Drug Administration has finalized a new food-safety rule under the Food Safety Modernization Act, designed to prevent food contamination during transportation. The rule will require those involved in transporting food and feed by ...
 Agri View5 days ago Groups Sue to Force FDA to Act on Chemical in Food Packaging  Before It's News3 days ago OSU names plant pathology and food safety expert to head national research and investigative lab  High Plains Journal5 days ago Global Food Additives Market to Reach US$39.8 bn by 2021 due to Increasing Expansion of Food and Beverage Industry  Press Release Ping5 days ago

Boston Scientific's ImageReady MR-Conditional Pacing System receives US FDA approval

Boston Scientific, a global medical technology leader, has received US Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady MR-Conditional Pacing ...
 PharmaBiz5 days ago Boston Scientific Receives U.S. FDA Approval For ImageReady(TM) MR-Conditional Pacing System  Healthcare Sales & Marketing Network2 days ago Stock Update (NYSE:BSX): Boston Scientific Receives U.S. FDA Approval For ImageReady MR-Conditional Pacing System  MoneyShow.com6 days ago BOSTON SCIENTIFIC : Receives U.S. FDA Approval For ImageReady MR-Conditional Pacing System  4 Traders6 days ago

FDA proposes ban on certain electrical stimulation devices

(Reuters) - The U.S. Food and Drug Administration on Friday proposed a ban on electrical stimulation devices (ESDs) that are used to curb individuals from engaging in self-injurious or aggressive behavior, saying they pose an "unreasonable and substantial" ...
 Reuters1 week ago New regs for Monday: Bomb suits, shock therapy, food  The Hill1 week ago

Orchid up 13% on USFDA successful inspection report for TN unit

"Orchid received the establishment inspection report (EIR) from US Food and Drug Administration based on the successful inspection closure for the API manufacturing facility located at Alathur, Kancheepuram district, Tamil Nadu," says the pharma company in ...
 Money Control3 weeks ago Torrent Pharma Dahej plant receives EIR from USFDA  Business Line1 month ago Alkem Labs up 5% on USFDA's inspection report for Gujarat unit  Money Control1 month ago Alkem Laboratories advances as Mandva plant gets establishment nod from USFDA  Business Standard1 month ago

Amid harsh prescription, get-well card from US drug regulator

MUMBAI: While Indian companies have been getting the rough end of the stick from the US Food & Drug Administration (FDA) with a plethora of inspections and warning letters, the run of bad news may have drowned out some of the more positive developments. The ...
 Economic Times2 weeks ago
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