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Diabetes Medication Article
FDA's Role in Regulating Insulin
FDA's Center for Drug Evaluation and Research (CDER) oversees drug products, including insulin. CDER makes sure that drugs sold in the U.S. are safe and effective. The center evaluates new types of insulin products, and it regulates the manufacturing, labeling, and advertising of insulin products.
Companies wanting to market insulin products are responsible for testing their products and submitting data showing they are safe and effective. At CDER, teams of doctors, statisticians, and scientists review new drug applications (NDAs). In some cases, FDA seeks help from advisory committees made up of outside experts.
Once a new insulin product is on the market, CDER monitors its quality and makes sure that its manufacturer follows FDA laws and regulations. CDER also monitors insulin products carefully after they are approved to identify any unexpected side effects. Through a system called MedWatch, health professionals and consumers can report serious adverse reactions to any medical product. CDER collects information from MedWatch and the drug industry and conducts statistical evaluations on drug usage, adverse reactions, poisonings, safety, and effectiveness. If necessary, CDER shares information with patients and health professionals.
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Actos Drug News
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Attorneys at SL Chapman LLC, a law firm dedicated to representing victims with Actos complications, are not surprised by the Federal Drug Administration's recent denial of Takeda Pharmaceuticals' proposed replacement for Actos (intended to the treat type 2 ...
Read moreActos Lawyers at SL Chapman React to FDA's Denial of Actos Maker Takeda's bid for Replacement Drug, Offer Free Special Report
Taylor Solano & Associates, known for taking on pharmaceutical companies for putting out dangerous drugs, has now focused its sights on Takeda Pharmaceuticals. Taylor, recently filed a lawsuit on behalf of his clients who were harmed by Actos. Taylor ...
Read moreTaylor Solano Takes On Takeda Pharmaceuticals In Federal Court Over Actos
An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.
Read moreActos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits
The FDA has decided to put off a decision on whether or not to approve Takeda Pharmaceutical Co Ltd ‘s diabetes drug alogliptin, which the company hopes will be the “successor to its top-selling Actos drug.”Actos lost its patent protection in 2011 ...
Read moreFDA delays decision on generic Actos
According to French Medicines Agency long-term use of Actos could increase bladder cancer occurrences by as much as 40 percent. Denver, CO (PRWEB) April 19, 2012 After the FDA warned in June, 2011 that the popular diabetes drug Actos might be associated ...
Read moreJudge Names Lead Actos Lawyers as Bladder Cancer Lawsuits Mount
A popular diabetes drug used by almost a quarter of a million Britons could also treat depression, say scientists. Actos, the brand name for pioglitazone, boosts the effects of antidepressants in patients whether they have diabetes or not according to new research.
Read morePopular diabetes drug 'could make anti-depressants more effective'
Health Canada also announced that the labels of this medication would be updated to warn users of the potential for Actos side effects. Health Canada is a governmental agency that acts in the same role as the FDA does in the United States, and the agency ...
Read moreHealth Canada Issues Statement Linking Actos to Risk of Bladder Cancer, Announces …
Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda ...
Read moreActos Bladder Cancer Lawsuit Filed by West Virginia Resident
Taking the diabetes drug Actos may increase one's risk of developing bladder cancer, Health Canada and the drug's maker, Takeda Canada Inc., say. The statement was the culmination of a safety assessment Health Canada announced last June, two days after the ...
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