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RTI-HS, FDA partner to study patients' preferences that contributed to approval of new obesity device
2015-02-02 14:32:07| Industrial Machines - Topix.net
RTI Health Solutions , a business unit of RTI International, partnered with the U.S. Food and Drug Administration to conduct a study on patients' preferences which contributed to the Agency's regulatory decision to approve the Maestro Rechargeable System, a first-of-kind device to treat obesity. In addition to clinical study results, FDA considered the study results to quantify patients' preferences for benefits and acceptability of risks of various obesity devices.
Tags: study
partner
device
approval
FDA approves Teva's generic version of AstraZeneca's Nexium
2015-01-27 00:13:34| Biotech - Topix.net
The U.S. Food and Drug Administration said it approved Teva Pharmaceutical Industries Ltd's generic version of AstraZeneca Plc's blockbuster heartburn drug Nexium, the agency's first such approval for the drug. The approval comes as generic drugmakers scramble to get their versions to the market and AstraZeneca is taken to court over so-called "pay-for-delay" settlements to delay the launch of generics to protect its drug's exclusivity.
Tags: version
generic
fda
approves
UPDATE 1-U.S. FDA approves NPS drug, in move validating Shire takeover deal
2015-01-24 06:29:54| Biotech - Topix.net
The U.S. Food and Drug Administration has approved NPS Pharmaceuticals Inc's drug Natpara to treat a rare hormone disorder, validating a bet by Shire Plc , which recently agreed to acquire NPS for $5.2 billion. Natpara is designed to treat hypoparathyroidism, a condition in which the body's parathyroid gland does not secrete enough parathyroid hormone .
Solazyme Receives FDA GRAS No Questions Letter For New Vegan Protein Source, Whole Algal Protein
2015-01-21 07:22:38| dairynetwork News Articles
Solazyme, Inc., a renewable oil and ingredients company, is pleased to announce that the US Food and Drug Administration (FDA) has issued a favorable response to Solazyme’s notification concluding that Whole Algal Protein is Generally Recognized as Safe (GRAS) as an ingredient in food and beverage products
Tags: questions
source
whole
letter
FDA and USDA launch programme for food safety in US
2015-01-19 01:00:00| Food Processing Technology
The US Food and Drug Administration (FDA) has collaborated with US Department of Agriculture's (USDA) National Institute of Food and Agriculture (NIFA) to monitor and manage the National Food Safety Training, Education, Extension, Outreach, and Techn
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