Fri, Oct 31st, 2008 | Archive |

WASHINGTON – The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.The consumer group, Public Citizen, filed a petition with the Food and Drug ...Read More

FDA Targets Drinks With Caffeine, Alcohol

Fri, Nov 13th, 2009 | Health, Most Viewed |

WASHINGTON -- The Food and Drug Administration is taking aim at caffeinated alcoholic drinks, saying it will pull them off the market unless manufacturers can prove the beverages are safe to drink. On Friday, the FDA sent letters to nearly 30 ...Read More

FDA holds off on oyster ban

Fri, Nov 13th, 2009 | Health |

Reporting from Atlanta - The Food and Drug Administration said today that it will conduct further studies before implementing a plan to ban raw, untreated Gulf Coast oysters during months when they are most likely to be infected with a ...Read More

Steel, rubber found in some Genzyme drugs

Fri, Nov 13th, 2009 | Health |

WASHINGTON/BOSTON (Reuters) - Stainless steel fragments, non-latex rubber and fiber-like material have been found in some drugs made by Genzyme Corp, dealing another blow to a company already struggling with manufacturing problems. The U.S. Food and Drug Administration said in a ...Read More

FDA: Caffeinated alcoholic drinks may be illegal

Fri, Nov 13th, 2009 | Health |

FDA: Caffeinated alcoholic drinks may be illegal (CNN) -- The Food and Drug Administration has notified about 30 manufacturers of alcoholic beverages containing added caffeine that it intends to take a look at their products. The question is not only if these products -- such as 24/7 made ...Read More

FDA Backs off Oyster Ban after Backlash

Fri, Nov 13th, 2009 | Health, SciTech |

Facing fierce resistance, the Obama administration on Friday backed off a plan to ban sales of raw oysters from the Gulf of Mexico during warm-weather months. The Food and Drug Administration said it would put the proposal on hold while it ...Read More

Foreign Particles Found In Genzyme Medicines

Fri, Nov 13th, 2009 | Health |

(Adds FDA comment, analyst reaction, and closing stock price, in the first, fourth through seventh, 16th and 17th paragraphs.) NEW YORK (Dow Jones)--The U.S. Food and Drug Administration on Friday warned doctors about foreign-particle contamination in a small percentage of five ...Read More

Another Swine Flu Vaccine Approved for Children

Fri, Nov 13th, 2009 | Health |

FRIDAY, Nov. 13 (HealthDay News) -- CSL Limited's H1N1 influenza vaccine has been approved by the U.S. Food and Drug Administration to include children 6 months and older, the agency said. Previously, the shot had been approved only for adults. The ...Read More

FDA Questions Safety of Caffeinated Alcoholic Drinks

Fri, Nov 13th, 2009 | Health |

FRIDAY, Nov. 13 (HealthDay News) -- Federal health officials said Friday that they plan to look into the safety and legality of making and selling popular alcohol drinks that contain caffeine. Prompted by a request from several states' attorneys general, the ...Read More

Web Giants Urge FDA to Update Ad Guidelines

Fri, Nov 13th, 2009 | Health |

FRIDAY, Nov. 13 (HealthDay News) -- Internet giants Google and Yahoo have lined up with the pharmaceutical industry in asking the U.S. government to draft new rules that would give drug companies more latitude to advertise online. Current U.S. Food and ...Read More

Foreign Particles Found In Some Genzyme Medicines

Fri, Nov 13th, 2009 | Health |

(Updates with details, FDA and company comment, and recent stock price) NEW YORK (Dow Jones)--The U.S. Food and Drug Administration on Friday warned doctors about foreign-particle contamination in a small percentage of five Genzyme Corp. (GENZ) medicines, marking another setback for ...Read More

FDA questions safety of alcoholic energy drinks

Fri, Nov 13th, 2009 | Health, U.S. |

WASHINGTON — The Food and Drug Administration is challenging makers of alcohol-infused energy drinks to prove their beverages are safe, citing complaints that the products can cause risky behavior and injury. The FDA issued a letter Friday to 30 beverage manufacturers, ...Read More

FDA finds bits of steel, rubber in Genzyme drugs

Fri, Nov 13th, 2009 | Health, Top Stories |

FDA finds bits of steel, rubber in Genzyme drugs WASHINGTON—Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues. The Food and Drug Administration said Friday that bits of steel, rubber and ...Read More

FDA seeks data on alcohol, caffeine in drinks

Fri, Nov 13th, 2009 | Health |

WASHINGTON (Reuters) - U.S. health regulators requested information from nearly 30 makers of caffeinated alcoholic beverages on why they believe their products are safe. The companies have 30 days to send data showing how caffeine can be "safely and lawfully" added ...Read More

US FDA: Some Genzyme drugs contaminated

Fri, Nov 13th, 2009 | Health |

* Particles in less than 1 pct of affected drugs * No health problems reported * Genzyme shares fall 5 pct WASHINGTON, Nov 13 (Reuters) - Stainless steel fragmentsand other foreign particles were found in batches of several ofGenzyme Corp's (GENZ.O) rare disease ...Read More

UPDATE 1-Cadence says FDA delays painkiller review by 3 months

Fri, Nov 13th, 2009 | Health |

* Extended action date on the painkiller is Feb 12, 2010 * Co says now planning for a launch early in Q2, 2010 * Shares fall 7 pct in pre-mkt trade Nov 13 (Reuters) - Drug developer Cadence PharmaceuticalsInc (CADX.O) said the U.S. ...Read More

FDA Hearing Addresses Drug Ads In Online Social Media

Fri, Nov 13th, 2009 | Health |

FDA Hearing Addresses Drug Ads In Online Social Media During a two-day public hearing hosted by the U.S. Food and Drug Administration, pharmaceutical companies, Internet firms and nonprofit organizations came out in droves to hear and be heard as federal officials discuss a potential need for the regulation of ...Read More

UPDATE 2-U.S. FDA tackles gray area of social media

Thu, Nov 12th, 2009 | Health |

* More than 800 people tried to register for FDA event * Lilly, Yahoo call for 'clarity' on FDA guidelines * FDA urged to communicate with Wikipedia, other sites (Recasts more comments from Google, Yahoo, Johnson & Johnson) WASHINGTON, Nov 12 (Reuters)- Drug ...Read More

FDA chief defends H1N1 vaccine supply

Thu, Nov 12th, 2009 | Health |

FDA chief defends H1N1 vaccine supply NEW YORK (Reuters) - The head of the U.S. Food and Drug Administration defended the agency's decision not to use an additive that could have stretched swine flu vaccine supplies, adding that doses should be coming more regularly. The vaccine to ...Read More

FDA tackles gray area of social media

Thu, Nov 12th, 2009 | Health |

WASHINGTON (Reuters)- Drug makers, Internet companies and nonprofits packed a hearing into what is a gray area for U.S. health regulators: how far Twitter, Wikipedia, blogs and other social media can go in promoting drugs. The two-day public hearing, convened Thursday ...Read More

Experts Tell FDA Not To Expect Too Much From Drug Ads On Web

Thu, Nov 12th, 2009 | Health |

WASHINGTON (Dow Jones)--Pharmaceutical experts and advertising specialists told the U.S. Food and Drug Administration on Thursday that the agency can't expect drug ads on Google, Facebook or other Web sites to present all risk information instantaneously. Several hundred pharmaceutical experts, advertising ...Read More