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FDA says Sandy delays decisions on some drugs

Posted: Published on November 3rd, 2012

(Reuters) - Health regulators will delay decisions on some drugs for up to two days because of the massive storm Sandy, which closed the federal government. The Food and Drug Administration said on Friday that the delay in meeting regulatory timelines for prescription drugs, medical devices and biosimilar drugs would apply to those with target dates around October 29 and 30, when offices were closed. For those drugs with target dates on October 31 or later, the agency will consider whether a delay is warranted, but it will not exceed two days. Sandy hit the East Coast late on Monday. The U.S. government closed ahead of the storm, and again on Tuesday due to widespread power outages and transit issues. The FDA has set times to review drugs under a user fee program that manufacturers help fund in return for the agency's meeting certain performance goals. For instance, it must review a certain percentage of drug applications within a set time. New drug application target approval dates under the Prescription Drug User Fee Act, or PDUFA, are closely watched because they indicate when companies will be able to start selling their new products. The Biosimilar User Fee Act - which … Continue reading →

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Drugs short after meningitis

Posted: Published on November 3rd, 2012

Elise Amendola / AP Two men stand guard outside the entrance to Ameridose LLC in Westborough, Mass., earlier this month. The firm has been temporarily shutted and has recalled all of its unexpired drugs because of Food and Drug Administration worries about sterility. By JoNel Aleccia, NBC News Fallout from a deadly outbreak of fungal meningitis blamed on contaminated pain shots may worsen the nations ongoing drug shortage crisis -- just as health officials were getting a handle on the problem. Food and Drug Administration officials say theyre taking urgent steps to ramp up production, distribution and even importation of six critical drugs after a sister company to the pharmacy at the heart of the outbreak voluntarily recalled all of its products this week because of concerns about sterility. FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems, officials said. Ameridose LLC, of Westborough, Mass., agreed to a voluntary shutdown and pulled more than 1,800 unexpired drugs this week after FDA inspectors saidthey couldnt guarantee the sterility of the medications. The firm is co-owned by owners the New England Compounding Center of … Continue reading →

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Roman Russian Market Food Store – Video

Posted: Published on November 3rd, 2012

Roman Russian Market Food Store Roman Russian Market, food store, tandyr made georgian bread, uzbek bread, lavash, lepeshka, home made bread, portland, food, cousine, kitchen, bakery, Roman Russian Market, Food Store in Portland, Oregon, Eastern European Food, Sausages, Deli, Pirozhki, Chebureki, Samsa, Pelmeni, Hot Bread, Bakery, Beverages, Best Wine selection, Juices, Baby Food, Marinades, Pickled vegetables, Smoked Fish, Black Caviar, Red Caviar, PharmacyFrom:Fantik BantikViews:10 0ratingsTime:01:12More inEntertainment Continued here: Roman Russian Market Food Store - Video … Continue reading →

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Hailstorm on All Saints' Day (France) – Video

Posted: Published on November 3rd, 2012

Hailstorm on All Saints' Day (France) copyright 2012 Lisa B. Falour, BS, MBA all rights reserved LISA, INC. (EURL) cutecatfaith.com This is Saint-Denis, just outside Paris, France. I have lots of clips up on my two channels here (the other is SLOBOMOTION) and on Dailymotion under "LisaFalour" which deal with the very changeable weather in Paris. Hallowe'en is not celebrated here. They try to introduce it kind of as a commercial thing, but really, it's not done here. (Nor is Christmas, that much, which is seen largely as a somewhat unimportant religious holiday. They consider other Christian holidays more important.) Christmas is just kind of "for the kiddies." But you do get two birthdays here every year. November 1 is a national holiday in France, and November 2 is Day of the Dead but they kind of blow that off. On the first, they visit the cemetery and take chrysanthemums. This year, Le Toussaint fell on a Thursday, so everyone was pretty happy (except for me -- I needed a doctor and a pharmacy and was out of luck) and arranged for Friday off -- they got a four-day weekend. There are usually three of these long … Continue reading →

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CSHP Happy Anniversary Video Take 1 – Video

Posted: Published on November 3rd, 2012

CSHP Happy Anniversary Video Take 1 CSHP Members and Students of Pharmacy participated in a fun and humorous video acknowledging CSHP's 50th Anniversary. This is one of three videos that was shown during Opening Session at CSHP's 2012 Seminar, Jackpot! Pharmacy.From:CSHPharmacistsViews:0 0ratingsTime:02:41More inNonprofits Activism Read the original here: CSHP Happy Anniversary Video Take 1 - Video … Continue reading →

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CSHP Happy Anniversary Video Take 3 – Video

Posted: Published on November 3rd, 2012

CSHP Happy Anniversary Video Take 3 CSHP Members and Students of Pharmacy participated in a fun and humorous video acknowledging CSHP's 50th Anniversary. This is one of three videos that was shown during Opening Session at CSHP's 2012 Seminar, Jackpot! Pharmacy.From:CSHPharmacistsViews:1 0ratingsTime:02:44More inNonprofits Activism Read the original: CSHP Happy Anniversary Video Take 3 - Video … Continue reading →

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Bioderma Review + French Pharmacy Haul | AlyAesch – Video

Posted: Published on November 3rd, 2012

Bioderma Review + French Pharmacy Haul | AlyAesch I went to France last Saturday and picked up a few French goodies 😉 And here's what I think of Bioderma and how I use it. AlysaFrom:alyaeschViews:2 1ratingsTime:08:05More inPeople Blogs Read the original: Bioderma Review + French Pharmacy Haul | AlyAesch - Video … Continue reading →

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Practice of Pharmacy – Video

Posted: Published on November 3rd, 2012

Practice of Pharmacy Recorded and Edited by Stephanie Music by Incompetech.comFrom:Laura CarpenterViews:0 0ratingsTime:04:25More inPeople Blogs More here: Practice of Pharmacy - Video … Continue reading →

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Shelton Louie – 2012 Alumni Fellow – Video

Posted: Published on November 3rd, 2012

Shelton Louie - 2012 Alumni Fellow Shelton Louie - 2012 Alumni Fellow, nominated by the College of Pharmacy. Oregon State University Alumni AssociationFrom:OSUaluViews:2 0ratingsTime:02:57More inEducation See the article here: Shelton Louie - 2012 Alumni Fellow - Video … Continue reading →

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TGL Negril 'The Good Life' – Video

Posted: Published on November 3rd, 2012

TGL Negril'The Good Life' Unorthodox Entertainment Presents The Good Life "escape to Dubai" Be apart of something extraordinary, even if it was just for one night. Early bird (Nov 15-30) $800 $1000 Presold $1300 @ The Gate Vip (Food and Drink Inclusive) $2000 Presold $3000@The Gate FREE Tequila shots all night Henna Tattoos Mardi Gras Beads on entry All access Bottle Lounge (Specials all night) Sophisticated Dubai Decor and Women ++Lots of Surprises Let's escape to dubai with Ultimate Dj mixology by: Yaadcore Rusti Covah Team Aftashakk Ticket Outlets Fontana Pharmacy- Montego Bay Jewel Box- Mid town Mall, Savanna-la-mar UG's Cellular (Digicel)- Lucea World of Sports- Negril Italian Cafe- Negril D'zone Sports Bar- Green Island Or Call 437-5456, 448-3229 pin:290cc7d5 Sponsors: ECS JUNGLE BOARDWALK BLAQINQ ALCHEMIST IRIEJAMZ JEWELBOX XPRESHUNZ ITALIAN CAFE Patrons and Friends 😀 Unorthodox Entertainment "Stay Different"From:djmairzViews:2 0ratingsTime:00:43More inEntertainment See original here: TGL Negril 'The Good Life' - Video … Continue reading →

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