Search For "food and drug administration"
US regulator conducts inspection of Piramal's unit in US
Updated : 3 years, 2 months ago IST
The company said it was preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines. The company said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the
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Lupin gets US regulator's nod for Prasugrel tablets used in heart ailments
Updated : 3 years, 2 months ago IST
The product will be manufactured at Lupin's facility in Goa, according to a statement from the pharma firm.
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Aurobindo Pharma arm receives regulator's nod to make, market Azacitidine
Updated : 3 years, 2 months ago IST
The product is expected to be launched this month, according to the statement from Aurobindo Pharma
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US FDA clears passage for pharmacies to dispense abortion pills
Updated : 3 years, 2 months ago IST
The US Food and Drug Administration has, for the first time cleared a passage for certified pharmacies to dispense abortion pills in the United States, Al Jazeera reported on Tuesday.
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US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Ina
Updated : 3 years, 2 months ago IST
Mumbai (Maharashtra) [India], January 3 (ANI/PRNewswire): Datar Cancer Genetics announced today that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra™-Glio', a blood test to help in the diagnosis of brain tumors. This is the thir
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Glenmark gets US drug regulator's nod for high BP medicine
Updated : 3 years, 2 months ago IST
Glenmark's Nicardipine Hydrochloride capsules of 20 mg and 30 mg will be distributed in the US by Glenmark Pharmaceuticals US, according to a statement from Glenmark.
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China halts some Taiwanese food imports over ingredients labeling issue
Updated : 3 years, 3 months ago IST
According to Taiwanese Food and Drug Administration (FDA) Director-General Wu Show-mei, all goods exported from Taiwan must be labeled with the ingredients and their percentage in the product.
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Alembic Pharma gets US regulator final nod for skin ointment - Desonide Cr
Updated : 3 years, 3 months ago IST
According to a statement from the Vadodara-headquartered pharma firm, the ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis U
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USFDA lists Sun Pharma's Halol unit under 'import alert'
Updated : 3 years, 3 months ago IST
According to a statement from the pharmaceutical company to the stock exchanges, the Import Alert implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with CGMP standards.
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Former Theranos executive Ramesh Sunny Balwani sentenced to nearly 13 year
Updated : 3 years, 3 months ago IST
In a statement, U.S. Attorney's Office said Balwani risked patient health by misrepresenting the accuracy of Theranos blood analysis technology and that defrauded Theranos investors of millions of dollars.
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Curadev Pharma receives FDA 'Study May Proceed' Letter for its Investigati
Updated : 3 years, 3 months ago IST
Boston (Massachusetts) [US]/ Noida (Uttar Pradesh) [India], December 6 (ANI/PRNewswire): Curadev Pharma, a small molecule drug discovery and development company focused on the generation of novel therapeutics for the treatment of intractable diseases such as cancer has received a Study May P
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Controversial Alzheimer's drug approval sparks surprising impact in US
Updated : 3 years, 3 months ago IST
When the U.S. Food and Drug Administration gave controversial accelerated approval to the first Alzheimer's drug in nearly 20 years, it had a surprising impact on attitudes about research into the disease. A survey by University of California, Irvine neuroscientists has found news coverage o
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