FDA Archives - Lets Talk Health

FDA approves new use for Roche’s Avastin in colon cancer treatment

01/23/2013 majac Your Health Matters

(Reuters) – The U.S. Food and Drug Administration on Wednesday approved the use of Roche’s Avastin for patients whose colorectal cancer has worsened despite previous treatment with the drug. The new use will allow patients first treated with Avastin plus chemotherapy to be treated again with the biotechnology drug in combination with a different chemotherapy regimen. A pivotal clinical trial showed that such a treatment strategy improved survival. …

Drug Administration, FDA, Roche Avastin

Changing food labels could boost understanding

01/23/2013 majac Your Health Matters

NEW YORK (Reuters Health) – Alternative nutrition labels that clearly display the total number of calories and other nutrients in an entire package might help consumers make healthier food choices, according to a new study from the U.S. Food and Drug Administration. FDA researchers found people were best at assessing chips and frozen meals – and comparing the healthfulness of multiple products – when nutrition facts were presented for the entire container’s worth of food or for both one serving and the whole container. …

Drug Administration, FDA

All-metal hip implants can damage soft tissue: FDA

01/17/2013 majac Your Health Matters

(Reuters) – Metal-on-metal hip implants can cause soft-tissue damage and pain, which could lead to further surgery to replace the implant, the U.S. health regulator said, following several recalls of the artificial hip parts. All-metal hip implants were developed to be more durable than traditional implants but have become a major cause of concern following several safety issues and user discomforts. The traditional implants combine a ceramic or metal ball with a plastic socket. The U.S. …

FDA, health

FDA: Cut Ambien Dosage for Women

01/10/2013 majac Your Health Matters

The U.S. Food and Drug Administration has announced today that it is requiring manufacturers of Ambien, Ambien CR, Zolpimist, Edluar, and other sleeping medications that contain the active ingredient zolpidem, to lower currently recommended doses.

Drug Administration, FDA

FDA requires lower doses for sleep medications

01/10/2013 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration is requiring makers of Ambien and similar sleeping pills to lower the dosage of their drugs, based on studies suggesting patients face a higher risk of injury due to morning drowsiness.

Drug Administration, FDA

FDA advisory panel backs J&J diabetes drug approval

01/10/2013 majac Your Health Matters

(Reuters) – A panel of advisers to the U.S. Food and Drug Administration recommended the agency approve an experimental new treatment for diabetes developed by Johnson & Johnson, potentially making it the first drug of its type to be approved in the United States. …

Drug Administration, FDA, Johnson Johnson, United States

FDA: New rules will make food safer

01/05/2013 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration says its new guidelines would make the food Americans eat safer and help prevent the kinds of foodborne disease outbreaks that sicken or kill thousands of consumers each year.

Drug Administration, FDA

FDA proposes sweeping new food safety rules

01/04/2013 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.

Drug Administration, FDA

New U.S. food safety rules by FDA seek more accountability

01/04/2013 majac Your Health Matters

(Reuters) – U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing food borne illnesses that kill or sicken thousands of Americans annually. The rules, required by the Food Safety Modernization Act (FSMA) that was signed into law two years ago, were announced by the U.S. Food and Drug Administration on Friday. The agency has come under heavy criticism for failing to introduce new food safety rules faster, but many of those critics applauded FDA’s announcement. …

Drug Administration, FDA

New food safety rules aim for more accountability

01/04/2013 majac Your Health Matters

(Reuters) – U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually. The new rules, required by the Food Safety Modernization Act (FSMA) that was signed into law two years ago, were announced by the U.S. Food and Drug Administration on Friday. "These proposed regulations are a sign of progress," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, who has been a critic of the FDA. …

Drug Administration, FDA

Abbott wins FDA approval for heart stent

01/03/2013 majac Your Health Matters

(Reuters) – Abbott Laboratories’ Xience Xpedition heart stent was approved by U.S. health regulators and will be launched in the United States immediately, the company said on Thursday. Heart stents are tiny tubular devices that prop open diseased blood vessels after angioplasty. Abbott’s stent delivers a drug, everolimus, which helps keep the vessel from reclogging. Abbott competes with Medtronic Inc and Boston Scientific in the market for heart stents. (Reporting By Debra Sherman; editing by John Wallace)

FDA, health, United States

FDA approves 1st new tuberculosis drug in 40 years

12/31/2012 majac Your Health Matters

WASHINGTON (AP) — The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.

Drug Administration, FDA, Johnson Johnson

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