美國將裁決佐劑和其它生物製品

美國裁決佐劑和其它生物製品 在美藥檢局的建議下可能被鬆開
US rules on adjuvants and other biologicals could be loosened under FDA proposals
Thursday, 01 April 2010 11:47

CBER建議的條例 放鬆構成材料的限制
CBER PROPOSED RULE EASES RESTRICTIONS ON CONSTITUENT MATERIALS

Biologics manufacturers could gain some leeway on constituent materials under a rule the FDA has proposed in response to technological advances in development and manufacturing. Current regulations on constituents such as preservatives, diluents, adjuvants, extraneous protein and antibiotics in biological products may be "unnecessarily restrictive," according to the FDA notice to be published in the March 30 Federal Register. Comments are due June 28. See proposed rule at http://www.fdanews.com/ext/files/2010-07073_PI.pdf
在一條美國藥檢局已建議的規例，用以回應在發展和製造的科技進步，生物製劑製造商在組成材料可能夠獲得一些迴旋餘地；現行法規對在生物製品中的成分如防腐劑、稀釋液、佐劑、多餘的蛋白質和抗生素，可能是“不必要的限制”，根據美國 藥檢局將3月30日發表的聯邦紀事公告。諮詢將在 6月28日到期。看建議的規例在http://www.blogger.com/%3Ca


Drug Industry Daily
http://www.fdanews.com/newsletter/article?issueId=13560&articleId=125719

http://www.theflucase.com/index.php?option=com_content&view=article&id=3192%3Aus-rules-on-adjuvants-and-other-biologicals-could-be-loosened-under-fda-proposals&catid=1%3Alatest-news&Itemid=64&lang=en