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Latest Articles in usfda
USFDA Disapproves Eli Lilly's Bowel Disease Drug
The agency's decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from rivals such as Abbvie Inc, Pfizer Inc, and Johnson & Johnson
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Alembic Pharma Gets USFDA Nod For Fluorouracil Injection
Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma
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No Covid Test Requirements For Pfizer, Merck Pills: USFDA
The health regulator said individuals with recent known exposure with signs and symptoms may be diagnosed by their healthcare providers with COVID even if they have a negative test result
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Glenmark's Baddi Facility To Supply Atovaquone To US On Exception: USFDA
Mumbai-based pharmaceutical company Glenmark on Friday said that its manufacturing facility in Baddi which was earlier kept under the import alert list by the USFDA in October 2022, will now be supplying Atovaquone Oral Suspension USP 750mg/5 to the US market as per the latest communication received by the company from the top US regulator
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USFDA To Probe Cough Syrups Made Overseas Along With Global Regulators
In a statement, the FDA said it had no indication that contaminated syrups had entered the US drug supply chain, but it is "investigating the potential impact and scope of this hazard on FDA-regulated products." The agency recommended consumers only take medicines which were made to be sold in the United States, especially for children
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USFDA Proposes One Covid Shot Per Year
The US health regulator on Monday proposed one dose of the latest updated COVID-19 shot annually for healthy adults, similar to the influenza immunization campaign, as it aims to simplify the country's COVID-vaccine strategy
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Evusheld May Not Protect Against Omicron Subvariant XBB.1.5: USFDA
The agency said it was closely monitoring the emergence of the XBB.1.5 subvariant, which accounted for 27.6 per cent of COVID-19 cases in the United States for the week ending Jan. 7
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6% Of Medicine Samples Of Substandard Quality In India
Furthermore, 50 (4 per cent) of 1,280 samples were again discovered to be of substandard quality in October
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Glenmark Pharma To Submit Corrective & Preventive Action Plan To USFDA
The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe, said the company
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Pfizer Awaits FDA Nod For Omicron-retooled Booster In Kids Under 5
The bivalent COVID-19 vaccine, which targets the original strain and the BA.4/BA.5 Omicron subvariants, is currently authorized as a booster dose for ages 5 years and older in the United States and the European Union (EU)
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USFDA Issues Fresh Observations At Aurobindo Pharma's Sangareddy Facility
The said Unit of Aurobindo Pharma had been classified as Official Action Indicated (OAI) on May 17, 2019 by the USFDA and the Company had responded to the agency and carried out the required corrective actions
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FDA To Relook At Infant Formula Production Rules To Prevent Bacterial Diseases
The Food and Drug Administration will also consider whether to establish a dedicated group of investigators and realign staff across two of its divisions to better support regulatory oversight of infant formula, among other measures, it said
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Zydus Receives EIR From USFDA For Its Moraiya Facility
The USFDA had inspected the facility from 26th July to 5th August, 2022 which concluded with four observations. The USFDA has indicated that the inspection is closed
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Doctors Request USFDA To Put Miscarriage Management On Abortion Drug
Danco, one of two U.S. companies that make the medicine, said that right now it has no plans to do so."At this time, we are not planning to submit (an application) for miscarriage management, but may reconsider in the future," a spokesperson said
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FDA Warns Of Cybersecurity Threat In Medtronic Insulin Pumps
The agency issued a cybersecurity risk alert for the Medtronic MiniMed 600 Series insulin pump system, which has several components including an insulin pump and a blood glucose meter that communicate wirelessly
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