Archive for February, 2008
Depomed Says Drug Reduces Hot Flashes - CNNMoney.com
Closed Published by Google Inc. February 12th, 2008 in Google FDA News, Regulatory AffairsDepomed Says Drug Reduces Hot FlashesCNNMoney.com - 3 hours agoGabapentin GR is an experimental, extended release version of gabapentin, which is already approved by the Food and Drug Administration for the treatment of …Depomed reports positive…
Consumer Information on: Endeavor® Zotarolimus-Eluting Coronary Stent on the Over-the-Wire (OTW), Rapid Exchange (RX), or Multi Exchange II (MX2) Stent Delivery Systems - P060033
Closed Published by CDRH Consumer News February 11th, 2008 in Regulatory AffairsThe Endeavor® Zotarolimus-Eluting Coronary Stent is a tiny, expandable, mesh-like tube made of a cobalt-based metal with a drug (called zotarolimus) contained within a thin polymer coating on its surface. The Stent is mounted over a deflated…
Earnings Preview: Genzyme - Houston Chronicle
Closed Published by Google Inc. February 11th, 2008 in Google FDA News, Regulatory AffairsEarnings Preview: GenzymeHouston Chronicle, United States - 9 hours agoAlso in October, Genzyme reported that the Food and Drug Administration sent a warning letter over problems with safety procedures for Thymoglobulin at a …
China SFDA: Buyers Must Vet Drug Safety - The Associated Press
Closed Published by Google Inc. February 11th, 2008 in Google FDA News, Regulatory AffairsMedPage Today2nd UPDATE: Baxter Halts Heparin Production Amid ReactionsCNNMoney.com - 1 hour agoA top Food and Drug Administration official said the agency has yet to identify the source of dozens reports of serious allergic reactions that have be…
Discovery Shares Jump on Drug Outlook - Houston Chronicle
Closed Published by Google Inc. February 11th, 2008 in Google FDA News, Regulatory AffairsDiscovery Shares Jump on Drug OutlookHouston Chronicle, United States - 1 hour ago… Laboratories Inc.'s troubled drug candidate Surfaxin on Monday, boosting shares on expectations for Food and Drug Administration approval in 2008. …Ah…
Life-Saving Advances Held Up by FDA - NewsMax.com
Closed Published by Google Inc. February 11th, 2008 in Google FDA News, Regulatory AffairsInjuryBoard.comLife-Saving Advances Held Up by FDANewsMax.com, FL - 2 hours agoMeanwhile, constant and lengthening delays by the Food and Drug Administration in approving new and vital medicines have sacrificed 10 times that many lives …$2…
CytRx gets FDA correspondence regarding Phase IIb arimoclomol ALS … - CNNMoney.com
Closed Published by Google Inc. February 11th, 2008 in Google FDA News, Regulatory AffairsBusiness Wire (press release)CytRx gets FDA correspondence regarding Phase IIb arimoclomol ALS …CNNMoney.com - 11 hours ago(NASDAQ:CYTR) Monday said it has received a letter from the Food and Drug Administration clarifying the FDA's decision…
LegalView Announces the Launch of a New Practice Area on Issues … - PR.com (press release)
Closed Published by Google Inc. February 11th, 2008 in Google FDA News, Regulatory AffairsLegalView Announces the Launch of a New Practice Area on Issues …PR.com (press release), NY - 2 hours agoThe practice area is being launched after the US Food and Drug Administration (FDA) released results from a review that found harmful a…
xTAG™ Respiratory Viral Panel (RVP)
Closed Published by Medical Device Approvals February 10th, 2008 in Regulatory AffairsThe xTAG? Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections. Acute… (Approved: 1/3/2008)
Trader Joe's to exclude some food imports from China - USA Today
Closed Published by Google Inc. February 10th, 2008 in Google FDA News, Regulatory AffairsTrader Joe's to exclude some food imports from ChinaUSA Today - 24 minutes agoStill, China's products show up often in food recalls, Food and Drug Administration data show. Of the 14 food recalls tracked by the FDA since Dec. …
Truth and rumours muddy plastics debate - National Post
Closed Published by Google Inc. February 10th, 2008 in Google FDA News, Regulatory AffairsTruth and rumours muddy plastics debateNational Post, Canada - 22 minutes agoThe committee is also asking if the Food and Drug Administration was wrong to conclude the chemical is safe for such uses. - After a parents' rally on …
Truth and rumours muddy plastics debate - National Post
Closed Published by Google Inc. February 10th, 2008 in Google FDA News, Regulatory AffairsHealth NewstrackTruth and rumours muddy plastics debateNational Post, Canada - 4 hours agoThe committee is also asking if the Food and Drug Administration was wrong to conclude the chemical is safe for such uses. - After a parents' rally …
Icy Hot Pain Patches Recalled After Burn Reports - ABC News
Closed Published by Google Inc. February 10th, 2008 in Google FDA News, Regulatory AffairsChattem recalls Icy Hot Heat Therapy productsMarketWatch - 3 hours agoAfter recent discussions with the Food and Drug Administration, however, Chattem said it decided on the recall for the Icy Hot Heat Therapy products. …Chattem Issues URGENT Vo…
FDA approval means cloned meat could make it to dinner tables - Dallas Morning News
Closed Published by Google Inc. February 10th, 2008 in Google FDA News, Regulatory AffairsCloned meat could soon be for dinner, if you're not paying attentionDallas Morning News, TX - 1 hour agoLast month, after years of debate, the Food and Drug Administration declared that meat and milk from most cloned livestock, and from …
Overburdened FDA poses national health risk - New Philadelphia Times Reporter
Closed Published by Google Inc. February 9th, 2008 in Google FDA News, Regulatory AffairsOverburdened FDA poses national health riskNew Philadelphia Times Reporter, OH - 2 hours agoAnyone paying attention to reviews of the Food and Drug Administration is aware by now that the regulatory agency is so overburdened, it poses a natio…
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