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Á¦¸ñ : "FDA Ãß°¡ º¸¿Ï ÇÊ¿ä¾ø´Ù" HLB, »óÇÑ°¡ Á÷ÇࡦºüÁø ¸¸Å ÁÖ°¡ ȸº¹?
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2024³â 07¿ù 03ÀÏ 13:20 ±èÁöÈÆ ±âÀÚ |
"FDA Ãß°¡ º¸¿Ï ÇÊ¿ä¾ø´Ù" HLB, »óÇÑ°¡ Á÷ÇࡦºüÁø ¸¸Å ÁÖ°¡ ȸº¹? |
HLB°¡ °£¾Ï ½Å¾à Çã°¡½É»ç¸¦ ¶Õ±â À§ÇØ ¹Ì±¹ ½ÄÇ°ÀǾ౹(FDA)°ú Á¢ÃËÇß´Ù´Â ¼Ò½Ä¿¡ »óÇÑ°¡¸¦ Âï¾ú´Ù.
3ÀÏ HLB´Â ÄÚ½ºÇÇ¿¡¼ ÀüÀÏ´ëºñ 30% ¿À¸¥ 7¸¸6800¿øÀ¸·Î »óÇÑ°¡¿¡ µµ´ÞÇß´Ù. À̳¯ HLB´Â °£¾Ï ½Å¾àÀÇ Çã°¡½É»ç Àç°³¸¦ À§ÇÑ FDA¿ÍÀÇ ¹ÌÆÃÀÌ 2ÀÏ(ÇöÁö½Ã°£) ¿Ï·áµÆ´Ù°í ¹àÇû´Ù.
HLB´Â ¹Ì±¹ ÀÚȸ»ç ¿¤·¹¹Ù¿Í Áß±¹ ÆÄÆ®³Ê»ç Ç×¼Á¦¾àÀÌ Âü¿©ÇÑ °¡¿îµ¥ ¿¸° ¹ÌÆÿ¡¼ FDA°¡ Ãß°¡ º¸¿Ï¼·ù¸¦ ¿äûÇÏÁö ¾Ê¾Ò´Ù°í ¼³¸íÇß´Ù.
FDA´Â CRL(º¸¿Ï¿äû¼½Å) ¹ß±ÞÀ¸·Î Áö¿¬µÆ´ø º»½É»ç ¼ÓÇà Á¶°ÇÀ¸·Î "Àç½É»ç ½Åû¼¸¦ Á¦ÃâÇÒ °ÍÀ» ±Ç°íÇÑ´Ù"´Â ÀÔÀåÀ» ³Â´Ù°í HLB´Â ÀüÇß´Ù.
HLB´Â "Ç×¼Á¦¾àÀº º°µµ ½ÇÇèÀ̳ª ¼·ù Áغñ ¾øÀÌ, ½Ç»ç ÀÌÈÄ 2Â÷·Ê¿¡ °ÉÃÄ Á¦ÃâÇÑ º¸¿ÏÀڷḦ ¹Ý¿µÇØ FDA¿¡ BLA(Çã°¡ ½Åû) ¼·ù¸¦ ´Ù½Ã Çѹø Á¦ÃâÇÏ¸é µÈ´Ù"°í Çß´Ù.
À̾î "FDA´Â ÇØ´ç ¼·ù Á¢¼ö ÈÄ ÆÇ´Ü ±âÁØ¿¡ µû¶ó ÃÖ´ë 2°³¿ù ¶Ç´Â 6°³¿ù·Î ½É»ç±â°£À» Á¤ÇØ ÇØ´ç ±â°£ ³» Çã°¡ ¿©ºÎ¸¦ °áÁ¤ÇÏ°Ô µÈ´Ù"°í Çß´Ù.
±èÁöÈÆ ±âÀÚ lhshy@mt.co.kr
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"FDA Ãß°¡ º¸¿Ï ÇÊ¿ä¾ø´Ù" HLB, »óÇÑ°¡ Á÷ÇࡦºüÁø ¸¸Å ÁÖ°¡ ȸº¹?
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