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Death Row Inmates Challenge U.S. FDA on Allowing Imports of Execution Drug
Twenty-one death row inmates asked a U.S. judge to order the Food and Drug Administration to block importation and use of a drug administered in executions, saying the anesthesia for lethal injections hasn’t been properly vetted by the agency.
FDA To Review Lower-Cost Versions Of Biotech Drugs
WASHINGTON -- The Food and Drug Administration is preparing to review the first lower-cost versions of biotech drugs, expensive medications that have never before faced generic competition in the U.S.
FDA sets draft rules for biotech drug copies
(Reuters) - The Food and Drug Administration's long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans. The proposed rules, issued on Thursday, require studies showing that the generic copies are "highly similar" to the originals, but there are several ways that might be proven. Because ...
Consumers want tougher probe of engineered salmon
WASHINGTON (Reuters) - Three consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat. The fish at issue, AquaBounty Technologies' AquAdvantage salmon, is currently classified as a new animal drug for the purposes of FDA review. The ...
FDA’s Oncologic Drugs Advisory Committee (ODAC) Votes to not Support Benefit/Risk Profile of DACOGEN® (decitabine) in ...
Astex Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 10 to 3 with one pers
Speedy Review for Roche Drug
Roche Holdings Ltd. recently announced that its Biologics License Application for pertuzumab has been accepted by the US Food and Drug Administration for review.
FDA will speed up review of Roche cancer drug
Swiss drugmaker Roche said Tuesday that the Food and Drug Administration will make a decision on its experimental breast cancer drug pertuzumab by June.
FDA panel votes against wider use of Amgen drug
WASHINGTON (Reuters) - An advisory panel on Wednesday recommended that U.S. health regulators reject the use of Amgen Inc's drug Xgeva to delay the spread of prostate cancer to the bone, dimming the chance of a wider use for one of the company's key growth drivers. The outside advisers to the Food and Drug Administration voted 12-to-1 that the benefits of the injectable drug, known chemically as ...
Mobius Therapeutics™ Receives Final FDA Approval for New Glaucoma Drug
ST. LOUIS, Feb. 9, 2012 /PRNewswire/ -- Mobius Therapeutics™, LLC, a St. Louis-based ophthalmic company, has received final approval from the U.S. Food and Drug Administration for the platform product, ...
Consumer groups want tougher probe of engineered salmon
WASHINGTON (Reuters) - Three U.S. consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat. The fish at issue, AquaBounty Technologies' AquAdvantage salmon, is currently classified as a new animal drug for the purposes of FDA review ...
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