Archive for October, 2007
China raises drug licensing standards after scandals over quality … - International Herald Tribune
Closed Published by Google Inc. October 29th, 2007 in Google FDA News, Regulatory AffairsReutersChina touts crackdown on tainted goodsInternational Herald Tribune, France - 8 hours agoLast summer, the government even executed the former head of the nation's food and drug administration, Zheng Xiaoyu, after he was convicted of…
A pediatrician's cough conundrum - Boston Globe
Closed Published by Google Inc. October 29th, 2007 in Google FDA News, Regulatory AffairsA pediatrician's cough conundrumBoston Globe, United States - 3 hours agoEarly this month, just before a hearing by the Food and Drug Administration, drug companies decided to pull from the market 14 multisymptom cold and cough …FDA pus…
Food safety agency to tackle pesticide concerns - Livemint
Closed Published by Google Inc. October 28th, 2007 in Google FDA News, Regulatory AffairsFood safety agency to tackle pesticide concernsLivemint, India - 52 minutes ago… saw the Indian parliament pass a new overarching food safety law last year to create an agency along the lines of the US Food and Drug Administration. …
FDA warns about 'stay awake drug' Provigil - News-Medical.net
Closed Published by Google Inc. October 28th, 2007 in Google FDA News, Regulatory AffairsFDA warns about 'stay awake drug' ProvigilNews-Medical.net, Australia - 1 hour agoThe US Food and Drug Administration (FDA) has issued a warning in connection with the drug Provigil because of dangerous side effects. …
Edwards: 2-Year Ban on New Drug Ads - The Associated Press
Closed Published by Google Inc. October 28th, 2007 in Google FDA News, Regulatory AffairsEdwards: 2-year Ban On New Drug AdsGuardian Unlimited, UK - 2 hours ago“But the (Food and Drug Administration) has been an ineffective watchdog, reviewing only a small fraction of ads. “It's time to stand up to the drug …
Article:Cehpeid Inc. of Sunnyvale to help defeat dangerous 'sup:/c … - San Francisco Chronicle
Closed Published by Google Inc. October 28th, 2007 in Google FDA News, Regulatory AffairsArticle:Cehpeid Inc. of Sunnyvale to help defeat dangerous 'sup:/c …San Francisco Chronicle, USA - 11 hours agoCepheid won Food and Drug Administration approval in April for its test for a life-threatening, antibiotic-resistant form o…
Exubera Proves No Sure Bets In Drug Making - TheDay
Closed Published by Google Inc. October 28th, 2007 in Google FDA News, Regulatory AffairsExubera Proves No Sure Bets In Drug MakingTheDay, CT - 4 hours agoThe assumptions in place when that process begins may no longer hold true years later when, and if, the drug gets Food and Drug Administration approval. …
Where do drug names come from? - Asbury Park Press
Closed Published by Google Inc. October 28th, 2007 in Google FDA News, Regulatory AffairsWhere do drug names come from?Asbury Park Press, NJ - 33 minutes agoAccording to the Food and Drug Administration's Web site, an 8-year-old died after receiving methadone instead of methylphenidate. A 19-year-old man showed …
Medical Journal - Nashua Telegraph
Closed Published by Google Inc. October 27th, 2007 in Google FDA News, Regulatory AffairsMedical JournalNashua Telegraph, NH - 1 hour ago… the new strain shrugs off all antibiotics that are currently approved by the federal Food and Drug Administration to fight ear infections in children. …
Garnier’s bitter medicine - Times Online
Closed Published by Google Inc. October 27th, 2007 in Google FDA News, Regulatory AffairsGarnier’s bitter medicineTimes Online, UK - 3 hours agoA report published this year by Price Waterhouse Coopers found that in 2006, the US Food and Drug Administration (FDA) approved just 22 new molecular …
IVAX Diagnostics, Inc. Announces Change in Strategic Direction to … - Business Wire (press release)
Closed Published by Google Inc. October 26th, 2007 in Google FDA News, Regulatory AffairsIVAX Diagnostics, Inc. Announces Change in Strategic Direction to …Business Wire (press release), CA - 5 hours ago… its previously announced target for submitting its 510(k) application for the PARSEC® System to the Food and Drug Adminis…
Barr's Generic Version of Estrostep(R) Fe Tablets Approved - CNNMoney.com
Closed Published by Google Inc. October 26th, 2007 in Google FDA News, Regulatory AffairsReutersBarr's Generic Version of Estrostep(R) Fe Tablets ApprovedCNNMoney.com - 5 hours ago… Inc., has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market…
Prasugrel concerns slam Lilly stock - Indianapolis Star
Closed Published by Google Inc. October 26th, 2007 in Google FDA News, Regulatory AffairsInside INdiana Business (press release)Prasugrel concerns slam Lilly stockIndianapolis Star, United States - 2 hours ago… maker's clot-buster called prasugrel is running into problems that are serious enough to delay or block approval f…
Consumer Information on: Epicel® cultured epidermal autograft (CEA) - H990002
Closed Published by CDRH Consumer News October 25th, 2007 in Regulatory AffairsEpicel® cultured epidermal autografts (CEAs), or skin grafts, are sheets of autologous keratinocytes (skin cells) used to replace the epidermal, or top layer of skin on severely burned patients. The patient?s own skin cells are grown or cultured from a…
US investigating generic antidepressant after complaints - International Herald Tribune
Closed Published by Google Inc. October 25th, 2007 in Google FDA News, Regulatory AffairsReutersUS investigating generic antidepressant after complaintsInternational Herald Tribune, France - 2 hours agoAP TORONTO: The US Food and Drug Administration said Thursday it is investigating complaints about a generic version of the antid…
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