Topic: Food and Drug Administration

Amgen, Watson to collaborate on cancer biosimilars

DEC 19 - Amgen Inc, the world's largest biotechnology company, and generic drugmaker Watson Pharmaceuticals Inc, said on Monday they will work together to develop and sell biosimilar versions of several biotech cancer drugs.The companies, which plan to sell biosimilar products under ...

FDA cites violations at three Novartis plants

(Reuters) - Drug regulators cited Novartis AG for "significant violations" of manufacturing regulations at its three generic drug plants in the United States and Canada, several of which were repeat offenses.U.S. Food and Drug Administration investigators found a lack of proper procedures ...

Government asks top court to rule for generic drugmaker

WASHINGTON (Reuters) - The government urged the Supreme Court to rule in favor of a generic drugmaker in a case over how companies can fight brand-name rivals to get cheaper drugs to market.The nation's top court on Monday heard arguments about whether ...

FDA sees huge opportunities in opening up drug data

LONDON (Reuters) - Regulators and drugmakers need to find ways to make more clinical data openly available, since vital knowledge about fighting disease is often locked away in confidential databases, the head of the U.S. drugs watchdog said on Monday.Food and Drug ...

FDA warns Mylan on Puerto Rico plant violations

(Reuters) - U.S. drug regulators found "significant violations" of manufacturing regulations at Mylan Inc's Caguas, Puerto Rico, facility, according to a letter posted on Tuesday.A Food and Drug Administration inspection earlier this year found that the generic drugmaker failed to complete a ...

U.S. doctors group supports fight on drug shortages

NEW ORLEANS (Reuters) - The American Medical Association threw its support behind government efforts to ensure the supply of lifesaving medicines but stopped short of recommending financial penalties against drug companies.The influential doctors' lobby voted on Monday to back legislation to create ...

FDA spurns Merck contraceptive, glaucoma drug

(Reuters) - The Food and Drug Administration has declined to approve an oral contraceptive and a glaucoma treatment being developed by Merck & Co Inc, but the drugmaker did not disclose details of the agency's concerns.Merck already sells both products in some ...
Supporters and producers of organic foods petitioned the US government Tuesday for mandatory labeling of genetically engineered foods, and encouraged consumers to go online and join the cause.The 21 petitioners want the Food and Drug Administration (FDA) to use the full power ...

U.S. FDA guidance on biosimilars may be imminent

NEW YORK (Reuters) - The U.S. Food and Drug Administration appears to be on the verge of issuing long-awaiting guidelines for the development of generic versions of complex biotechnology medicines.The FDA still plans to release the guidance by the end of the ...

Fear in US as drug shortages mount

Shortages of vital drugs, particularly cancer-fighting medication, have raised concerns in the United States, where regulators often have to race to try to find replacements.A recent report by the Food and Drug Administration (FDA) found that the number of important treatments that ...
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