原站：http://www.fda.gov

标签：food

指数：

“Food and Drug Administration--Press Releases”的内容更新

累计：1058 篇（自 2007-09-03 起）

更新：约5篇/周，最后更新17 小时前

Food and Drug Administration--Press Releases

FDA seeks $4.5 billion to support medical product de

the u.s. food and drug administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the president’s fiscal year (fy) 2013 budget – a 17 percent increase over the fda enacted budget for fy 2012. industry user fees would fund 98 percent of the proposed budget increase. the fy 2013 request covers the period fro... (17 小时前)

http://inezha.com/w/5mmh6a58

Food and Drug Administration--Press Releases

New Jersey company agrees to halt production of unap

accurate set inc., of newark, n.j., and the company’s president and owner, cornell l. adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.... (19 小时前)

http://inezha.com/w/44wela5e

Food and Drug Administration--Press Releases

FDA investigating illegal online sale of handheld de

the u.s food and drug administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental x-ray units. the fda is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful x-rays. the units, sold online by manufact... (3 天前)

http://inezha.com/w/cld15a56

Food and Drug Administration--Press Releases

FDA issues draft guidance on biosimilar product deve

the u.s. food and drug administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the united states.... (4 天前)

http://inezha.com/w/13msit5u

Food and Drug Administration--Press Releases

FDA and industry reach agreement in principle on med

the fda and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. the recommendations would authorize the fda to collect $595 million in user fees over five years, plus adjustments for inflation. details of the agreement, such... (12 天前)

http://inezha.com/w/pnwa1t5a

Food and Drug Administration--Press Releases

FDA approves Gleevec for expanded use in patients wi

the u.s. food and drug administration today granted gleevec (imatinib) regular approval for use in adult patients following surgical removal of cd117-positive gastrointestinal stromal tumors (gist). today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.... (13 天前)

http://inezha.com/w/3udg7t5q

Food and Drug Administration--Press Releases

FDA approves Kalydeco to treat rare form of cystic f

the u.s. food and drug administration today approved kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (cf) in patients ages 6 years and older who have the specific g551d mutation in the cystic fibrosis transmembrane regulator (cftr) gene.... (13 天前)

http://inezha.com/w/6xmr6t5y

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