Search Results for "Food And Drug Administration Philippines Mandates"

04:14 EDT 26th April 2015 | BioPortfolio

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Oral Administration

Abiraterone Acetate - Zytiga

On April 28, 2011, the US Food and Drug Administration (FDA) approved Zytiga (abiraterone acetate), for use in combination with prednisone for the second-line treatment of castration-resistant prost...

Food Allergy

ImmTAC

Immunocore’s ImmTAC technology enables the immune system to recognise and kill cancer or viral cells. T Cell Receptors naturally recognise diseased cells and Immunocore’s competitive ad...

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US Food and Drug Administration and Design of Drug Approval Studies

To enhance protocol quality, federal regulations encourage but do not require meetings between pharmaceutical companies and the US Food and Drug Administration (FDA) during the design phase of pivotal...

Ebola volunteers wrestle with quarantine mandates

Dr. Robert Fuller didn't hesitate to go to Indonesia to treat survivors of the 2004 tsunami, to Haiti to help after the 2010 earthquake or to the Philippines after a devastating typhoon last year. But...

FDA Guards Against Food Spoilage, Contamination

Food and Drug Administration analysts and entomologists investigate product samples and protect consumers from spoiled and contaminated food.

Xadago (Safinamide) New Drug Application (NDA) Accepted For Filing By The U.S. Food And Drug Administration (FDA)

Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel central nervous system (CNS) and pain therapies, and its commercial and development partner, Z...

FDA Cautions Against 'Undeclared' Food Allergens

TUESDAY, Oct. 28, 2014 -- Some food labels may not reliably list all possible food allergens, according to the U.S. Food and Drug Administration. The agency added that these "undeclared allergens" are...

US measles outbreak worst for 15 years

The worst measles outbreak in 15 years has reached a startling 121 cases in the US alone according to the Centers for Disease Control and Prevention (CDCP). Analysis conducted by the institute shows t...

Par Pharmaceutical gets FDA approval of Vasostrict

Par Pharmaceutical has received approval for its new drug application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the US Food and Drug Administration (FDA) pursuant to section 5...

Obama Administration Proposes New Food Safety Agency, Consolidating Parts of USDA and FDA

WASHINGTON - President Barack Obama is proposing a new government agency dedicated to keeping the nation's food safe. It would consolidate parts of the Agriculture Department and the Food and Drug Adm...

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Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device Beyond the U.S. Food and Drug Administration-Approved Duration.

To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration (FDA)-approve...

Postmarketing Review of Intravenous Acetaminophen Dosing Based on Food and Drug Administration Prescribing Guidelines.

To evaluate the appropriateness of intravenous acetaminophen dosing-prescribed dose, frequency, duration, and indication-based on United States Food and Drug Administration (FDA)-approved prescribing ...

Assessing the Safety and Effectiveness of Devices After US Food and Drug Administration Approval: FDA-Mandated Postapproval Studies.

Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to cond...

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

The authors conducted a study to determine the frequency and type of adverse events (AEs) associated with dental devices reported to the Food and Drug Administration Manufacturer and User Facility Dev...

Drug Development and FDA Approval, 1938-2013.

This interactive graphic shows major legislative and regulatory events related to approval of new drugs by the Food and Drug Administration (FDA), drug approvals by year and by therapeutic category, a...

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