ÄÚ¹ÌÆÊÀº PAX-1(KOMINOX) ¾Ï¼ºÅëÁõ ÀÓ»ó2»ó A, B °èȹ °á°úº¸°í¼ Àμö¸¦ À§ÇÑ °¡¾Ð·ù(Àڻ굿°á)¸¦ ÁøÇàÇÑ´Ù°í 15ÀÏ °ø½ÃÇß´Ù. °¡¾Ð·ù ´ë»óÀº È£ÁÖ ¼ÒÀç Bio and Gene PtyÀÇ È¸»ç ÀÚ»ê ¹× ´ëÇ¥ Andrew Han(Çѱ¹¸í ÇÑ¿µÅÂ)¿¡ ´ëÇÑ °³ÀÎÀÚ»êÀÌ´Ù.
ÄÚ¹ÌÆÊÀº È£ÁÖ¹ýÀΰú Bio and Gene Pty, Ltd ´ëÇ¥ ÇÑ¿µÅÂÀÇ »ç¾ÇÇÏ°í ºÎÁ¤Á÷ÇÑ ÇàÀ§¿¡ ´ëÇÏ¿© È£ÁÖ¹ý¿ø¿¡ Bio and Gene Pty,Ltd ¿Í ´ëÇ¥ Andrew Han(Çѱ¹¸í:ÇÑ¿µÅÂ)À» »ó´ë·Î ȸ»çÀÚ»êÀº ¹°·Ð ÇÑ¿µÅ °³ÀÎÀڻ꿡 ´ëÇÏ¿© È£ÁÖ ¹× Çѱ¹ ±×¸®°í Àü¼¼°è ¸ðµÎ¿¡ ´ëÇÏ¿© °¡¾Ð·ù ¿äûÀ» ½ÅûÇѹ٠ȣÁÖ¹ý¿øÀ¸·Î °¡¾Ð·ù(=Àڻ굿°á)Á¶Ä¡°¡ °áÁ¤µÆ´Ù°í ¹àÇû´Ù.
ÄÚ¹ÌÆÊÀº 2018³â 3¿ùºÎÅÍ 12¿ù±îÁö ¼öÂ÷·Ê¿¡ °ÉÃÄ ÀÓ»ó°ü·Ã Á¡°Ë¹×Á¶»ç(Inspection), ÀÓ»ó¿Ï·áº¸°í¼¸¦ °ÅÀýÇß´Ù°í µ¡ºÙ¿´´Ù.
ÄÚ¹ÌÆÊÀº ¹ý¿øÀ» ÅëÇÏ¿© ÇØ°áÄÚÀÚ ³ë·ÂÇÑ °á°ú ÃÖ±ÙÀÇ È£ÁÖ ºòÅ丮¾ÆÁÖ ´ë¹ý¿ø Á¶Ä¡¿¡ µû¶ó Á¶»ç¸¦ ½Ç½Ã ÇÑ ¹Ù PAX-1ÀÇ Pharmacovigilance System¿¡ ÀÇÇØ FDA¿¡ º¸°íµÈ ºÎÀÛ¿ëÀÌ ¾øÀ½¿¡µµ ºÒ±¸ÇÏ°í '¼öÂ÷¿¡ °ÉÃÄ ÀÓ»ó½ÃÇèÁß ½É°¢ÇÑ ºÎÀÛ¿ëÀÌ ¹ß»ýÇÏ¿´´Ù°í ´ç»ç¿¡ Å뺸ÇÑ »ç½Ç ¸ðµÎ°¡ Bio and Gene Pty, Ltd ´ëÇ¥ ÇÑ¿µÅ°¡ ¾ø´Â »ç½ÇÀ» ÀÖ´Â °Í ó·³ ÇãÀ§·Î Á¶ÀÛÇÏ¿© Å뺸ÇÏ¿´´Ù´Â »ç½ÇÀÌ Á¶»ç°úÁ¤¿¡¼ ¹àÇôÁ³´Ù°í µ¡ºÙ¿´´Ù.
±è»ç¶û ±âÀÚ kimsarang0420
<ÀúÀÛ±ÇÀÚ © ÆʽºÅ¹, ¹«´Ü ÀüÀç ¹× Àç¹èÆ÷ ±ÝÁö>