Menu
What are you looking for?

¿ÎÌà ´Óµøå´Æð·üµÄ°¸Àý¶´²ì»ñÒæ·çÏÕ¾ö²ß±³ºóµÄ¿¼Á¿

Source:adminAuthor:admin Addtime:2024/02/09 Click:

¡¡¡¡ÔÚÈ¥Äê12ÔÂÏßÌìÀíÂÛ֪ʶµÄ»ù´¡ÉÏ £¨µã»÷²é¿´£© £¬2023Äê3ÔÂ17-18ÈÕ£¬×¿Ô½È˲ÅÅàÑøÏîÄ¿Ò©ÎïÑз¢¹Ø¼ü¾ö²ßÁ¦“

¡¡¡¡ÔÚ8λÀ´×Ôº£ÄÚÍâ¾ßÓзḻÉóÆÀ¾­Ñé»òÐÐҵʵ¼ù¾­ÑéµÄ¿Î³Ì½ÌÊÚ¼°ÏîÄ¿µ¼Ê¦ÃǵÄÖ¸µ¼Ï£¬Í¨¹ý¾­µä°¸Àý·ÖÎöºÍ½ÇÉ«Ä£ÄâÑÝÁ·£¨¼à¹Ü»ú¹¹/Éê°ì·½/ר¼Ò×ÉѯίԱ»á£¬FDA/Sponsor/AC£©£¬ÕæʵÔÙÏÖ²¢ÉîÈëÆÊÎö²úÆ·²»Í¬½×¶Î»ñÒæ·çÏÕ¾ö²ß±³ºóµÄ¿¼Á¿ÒòËغͲ»Í¬½ÇÉ«ÔÚ»ñÒæ·çÏÕ¾ö²ßÖеĹØ×¢Òªµã¡£

¡¡¡¡1) È«³ÌʵսģÄ⣺ѧԱʵսÐÔµÄÈ«³ÌÑÝÁ·Ä£ÄâFDA/Sponsor/AC³ÉÔ±ÔÚר¼Ò×ÉѯίԱ»áµÄ×¼±¸¼°»áÒéÉϵľö²ß¹ý³Ì¡£

¡¡¡¡2£©ÏÖ³¡·ÖÎö²¢»¹Ô­°¸ÀýµÄµøå´Æð·ü£º×÷Ϊ±¾¿Î³ÌÖ÷ÒªÉè¼ÆÕߣ¬Florence Houn²©Ê¿£¨ÃÀ¹úFlorence Houn MD MPH LLC¹«Ë¾×Éѯ¹ËÎÊ£¬Ô­ÃÀ¹úFDAÐÂÒ©ÉóÆÀÈý²¿²¿³¤£©ºÍÀî×ÔÁ¦²©Ê¿£¨Ç¿Éú¼¯ÍÅÑîÉ­ÖÆÒ©È«ÇòÒ©ÎïÑз¢¸±×ܲá¢ÑÇÌ«Ñз¢ÖÐÐĸºÔðÈË£©£¬Ç×Éí¾­Àú¸Ã°¸ÀýÔÚÃÀ¹úFDAµÄÉóÆÀ¹ý³Ì£¬Í¬Ê±×÷Ϊ±¾´Î¿Î³ÌµÄÊÚ¿ÎÀÏʦºÍ¹ËÎÊÇ××Ô²ÎÓë¿Î³Ì½²ÊÚÓ뻥¶¯£¬½áºÏÊÚ¿ÎÀÏʦǰÆÚ²éÔĵĴóÁ¿×ÊÁϺÍѧԱµÄÏÖ³¡ÑÝÁ·£¬Ò»Æð»¹Ô­ÔÙÏÖÁË°¸ÀýÒ©Æ·“ÉúÉúËÀËÀ”ÃüÔ˶àⶵÄ3Ä꣬´ÓÉÏÊÐÉêÇëµ½ÉÏÊк󷴷´¸´¸´»ñÒæ·çÏÕÆÀ¹ÀºÍ¾ö²ßµÄÈ«¹ý³Ì¡£

¡¡¡¡3£©×ÊÉʦÏÖ³¡¸¨µ¼£º¸÷С×é·Ö±ðÖ¸ÅÉ1ÃûÀ´×Ô¹úÄÚÍâÓÐÐÐҵʵ¼ù¾­ÑéµÄÏîÄ¿µ¼Ê¦È«³Ì¸¨µ¼£¬¸ù¾ÝËù°çÑݵĽÇÉ«£¨FDA/Sponsor/AC£©¶Ô°¸ÀýÒ©Æ·µÝ½»µÄÊý¾ÝºÍÉêÇëµÄÊÊÓ¦Ö¢½øÐлñÒæ·çÏÕÆÀ¹À¡£Í¨¹ýÏîÄ¿µ¼Ê¦µÄ¸¨µ¼ºÍ¶àÂÖµÄѧԱ½ÇÉ«°çÑÝ¡¢×éÄÚÌÖÂÛÒÔ¼°×é¼äµÄ¼¤±ç£¬Í¬Ñ§ÃǶԻñÒæ·çÏÕÆÀ¹ÀµÄ¿ò¼Ü¡¢¿¼Á¿ÒòËغ;ö²ß¹ý³Ì´Ó³õ²½Á˽⵽ÊìÁ·ÕÆÎÕ¡£

¡¡¡¡2ÌìµÄ°¸ÀýÄ£ÄâÑÝÁ·£¬»ùÓÚʦ×ÊÍŶӶԿγÌÄ¿±êµÄ¾«ÐÄÉè¼Æ£¬Í¬Ñ§ÃÇÉî¿ÌÁ˽⵽²úÆ·µÄ»ñÒæ·çÏÕÆÀ¹À¹á´©ÆäÈ«ÉúÃüÖÜÆÚ£¬´ÓÑз¢µ½ÉÏÊÐÅú×¼ÔÙµ½ÉÏÊк󡣴ËÍ⣬´ÓÁÙ´²Ñо¿ºÍÉÏÊкóµÄ²úÉúµÄÐÂÊý¾Ý»á´òÆÆ֮ǰµÄ»ñÒæ·çÏÕƽºâ¡£³ÖÐø»ñµÃÓйØÒ©Îï»ñÒæºÍ·çÏÕµÄÐÂÐÅÏ¢£¬¿ÉÄÜ»á½â´ð´ËÇ°ÒÅÁôµÄÎÊÌ⣬¼õÉÙÒ©ÎïµÄ²»È·¶¨ÐÔ£»µ«Ò²¿ÉÄÜ·¢ÏÖеIJ»È·¶¨ÐÔºÍÐµİ²È«ÐÔÎÊÌ⣬´Ó¶øÓ°Ïì»ñÒæ·çÏÕµÄÆÀ¹À¡£

¡¡¡¡FDA/Sponsor/AC¸÷·½Ëù´¦Î»Öò»Í¬£¬ÈÏÖªÉÏ´æÔÚÖî¶à²îÒ죬µ«´ó¼ÒµÄÄ¿±êÒ»Ö£¬¼´£º×îÖÕÄ¿µÄÊDZ£»¤»¼ÕßÔÚ»ñÈ¡×î´óÀûÒæµÄÇ°ÌáÏ°²È«ÓÃÒ©¡£

¡¡¡¡Í¨¹ý2ÌìµÄʵսÑÝÁ·£¬Í¬Ñ§ÃÇÕæÕýÀí½âÁËÀî×ÔÁ¦²©Ê¿ÔÚ¿ª°àÖ嫂 £¨µã»÷²é¿´£© ÖÐÌáµ½µÄÔÚ»ñÒæ·çÏÕÆÀ¼ÛµÄѧϰÖУ¬ÐèÒªÕÆÎÕµÄ3¸ö¹Øϵ£º

¡¡¡¡³ýÁË°¸ÀýÖÐÌÖÂÛµÄÒ©Î»ñÒæ·çÏÕÆÀ¼ÛÒ»Ö±ÊÇÒ©Æ·¿ª·¢ÉóÆÀÖеĽ¹µãÎÊÌâ¡£ÀýÈ磬aducanumabµÄ¿ª·¢ÒÔ¼°ÉÏÊÐÉêÇëÒ»Ö±±¶Êܸ÷·½¹Ø×¢²¢±¥ÊÜÕùÒ顣κÏþÐÛ²©Ê¿´øÁìͬѧÃÇÒ»ÆðѧϰÁËÆ俲¿ÀµÄÑз¢ºÍÉÏÊÐ֮·£¬¼°»ñÅú±³ºó»ñÒæ·çÏÕµÄÕùÒéºÍ¿¼Á¿¡£ÃÀ¹úFDAͨ¹ý¼ÓËÙÉóÅú;¾¶Åú×¼ÆäÓÃÓÚÖÎÁÆ°¢¶û´Äº£Ä¬Ö¢£¨AD£©£¬µ«»ñÅú²¢²»Òâζ×ÅÁÙ´²ÊÔÑéµÄ½áÊø£¬Éê°ì·½ÈÔÐè¼ÌÐø½øÐÐÏà¹ØÑо¿ÒÔÈ·ÈÏÔ¤ÆÚµÄÁÙ´²»ñÒ棬ÑéÖ¤Ìæ´úÖÕµãÓëÁÙ´²»ñÒæµÄʵ¼ÊÁªÏµ¡£

¡¡¡¡Àî×ÔÁ¦²©Ê¿ÌáÐÑͬѧÃÇ£¬FDA²¢·ÇÒ»³É²»±ä£¬ÆäÔÚÉóÅú¹ý³ÌÖ⻶ÏÍ»Æƾɵıê×¼²¢½¨Á¢Ðµıê×¼£¬Åú»ò²»ÅúµÄ“»ñÒæ·çÏÕÆÀ¼Û”ÓÀÔ¶»áÒÔ±£³ÖFDA¹«ÐÅÁ¦ÎªºËÐÄ¡£Ï£Íûͨ¹ý°¸ÀýÄ£ÄâÑÝÁ·ºÍ½ÇÉ«°çÑÝ£¬Äܹ»×ª»»Ë¼Î¬£¬Éî¶ÈÀí½â»ñÒæ·çÏÕµÄƽºâ£¬¶´²ì¼à¹Ü»ú¹¹µÄ˼άģʽ¼°Æä±³ºóµÄ¿¼Á¿¡£

¡¡¡¡¸Ðл°¸ÀýµÄÇ×ÀúÕßFlorence Houn²©Ê¿¡¢Àî×ÔÁ¦²©Ê¿¹ØÓÚFDAÒ»ÊÖ¾­ÑéµÄ·ÖÏí£¬ÓÈÆä¸ÐлÀî×ÔÁ¦²©Ê¿È«³ÌÊÊʱ²¢Òý·¢Éî˼µÄϬÀûµãÆÀ£¡¸Ðл¿Î³Ì½ÌÊÚ&ÏîÄ¿µ¼Ê¦ÎºÏþÐÛ²©Ê¿¡¢µÒ¼ÑÄþ²©Ê¿¡¢Íõ²ÊºçÀÏʦ¡¢ÂÞÂü²©Ê¿¡¢ÕÅÓ¾§²©Ê¿¡¢Íõ»ÝÄÈÀÏʦÃæ¶ÔÃæµÄϤÐĸ¨µ¼£¡¸ÐлͬѧÃdzÁ½þʽͶÈ룬ÎÒÃǹ²Í¬´òÔìÁ˴˴ξ«²ÊµÄ°¸Àý½Ìѧ»¥¶¯¿ÎÌã¡

¡¡¡¡3ÔÂ17ÈÕÍí£¬Í¬Ñ§ÃÇÒ»ÆðÌýÈ¡Á˱Ͼ®ÈªÏÈÉú¡¢Àî×ÔÁ¦²©Ê¿Î§ÈÆÖйúÒ©Æ·¼à¹ÜµÄÏÖ´ú»¯·¢Õ¹ÓëδÀ´Õ¹¿ªµÄÒ»³¡ÈÈÁÒ¶øÒâÓÌδ¾¡µÄ¡ºÎ§Â¯Ò¹»°¡»¡£

¡¡¡¡·ëɺ£¨¶«ê×Ò©Òµ×¢²á·¨¹æÊÂÎñ²¿¸ß¼¶×ܼࣩ£º·ÖÏíÕâÁ½ÌìµÄѧϰÊÕ»ñ£¨°üÀ¨Î§Â¯Ò¹Ïߣ©ÊáÀí¹¹½¨ÁË»ñÒæ·çÏÕÆÀ¼ÛµÄ»ù±¾Âß¼­£ºÊý¾Ý£¨Õæʵ¡¢×¼È·¡¢ÍêÕû£©—±ê×¼ÓëÅжϡ¾¿Æѧ¡¢ºÏÀí¡¢¹«Æ½£¬°üÀ¨ÁÙ´²Éè¼Æ¡¢ÆÀ¼Û±ê×¼£¨»ñÒæ·çÏÕ£º±ÈÀý/³Ì¶È/ƵÂÊ£¬¸öȺ/Ö÷¿Í¹Û/Ïà¶ÔÐԵȣ©—¾ö²ß£¨ÊÇ·ñÅú¡¢ÈçºÎÅú£©¡¿£»£¨2£©ÉîÈëÀí½â¼à¹ÜÔÚ¼ùÐз¨¹æÒªÇóʱÊ÷Á¢·¨ÖÎ˼άµÄÖØÒªÐÔ£¬¼à¹ÜÁé»îÐÔÐèÒªÏÞÖÆÔÚ·¨¹æ·¶Î§ÄÚ£¬¼à¹Ü¾ö²ßÒ²ÐèҪƽºâЧÂÊÓ빫ƽ¡£

¡¡¡¡³ÂСÁÁ£¨°²ÄþÊÐÈËÃñÒ½ÔºÒ»ÆÚÁÙ´²ÊÔÑéÑо¿ÖÐÐÄ£©£º£¨1£©»ñÒæ·çÏÕÆÀ¼Û¿Î³ÌÖÐpublic hearingµÄclarifying questions£¬¸ø¹¤×÷µÄÆôʾÊÇ£¬×÷ΪÖ÷µ¼Õ߶ø²»ÊDzÎÓëÕߣ¬ÓÅÏÈÊÂÏîÊǽ¨Á¢¹æÔò¡¢Î¬³ÖÖÈÐò£»£¨2£©SponsorÈç¹û²»ÄÜÊÂÏȶÔmartialsºÍsource dataµÄÍêÕûÐÔ×ö³ö×ã¹»µÄ×¼±¸£¬¿ÉÄÜ»á´æÔÚ²»ÄÜÔڼȶ¨¡¢Ô¤Æڵķ¶Î§ÄÚÌÖÂÛÎÊÌâµÄ·çÏÕ£»£¨3£©°¸Àý½Ìѧģʽ³£ÓУ¬½²Õ߶԰¸ÀýµÄÉî¶ÈÀí½â²»³£ÓУ¬¿Î³Ì½ø³ÌºÍÌÖÂÛʼÖÕ¾Û½¹ÅàѵĿ±ê£¬²»½ö´«ÊÚ¼à¹Ü¿Æѧ£¬¸üÓмà¹ÜÕÜѧ¡£¸ÐлÒàºëÉÌѧԺºÍ¿Î³ÌÍŶÓÂþ³¤µÄ×¼±¸ºÍ¾«ÐĵĴòÄ¥£¬Ê«ÒâÇ黳£¬½³Ðľ«Éñ£¡

¡¡¡¡·ëºìÔÆ£¨±±¾©Ë¹µ¤Ä·Èü¶ûÒ©Îᆵ½ä²¿/ÒßÃçҽѧ²¿¸ºÔðÈË£©£º»ñÒæ·çÏÕÆÀ¹ÀÊÇÒ»¸ö·Ç³£ÆÈÇе«ÓÖ¸´ÔӵŤ×÷ÄÚÈÝ£¬ÆÀ¹À¹ý³ÌÖÐÐèҪȫÃ濼ÂǸ÷Ïà¹ØÖ¤¾Ý¡£±¾´ÎµÄ¿Î³ÌÉè¼ÆÊ®·ÖÍêÉÆ£¬²ÎÓ뵼ʦÎÞÂÛÊÇÇ°ÆÚµÄ×¼±¸»¹ÊÇÔÚÊڿιý³ÌÖоùÊ®·ÖÓÃÐĺÍͶÈë¡£´Ó»ù´¡ÀíÂÛºÍʵ¼Ê°¸Àý³ö·¢£¬ÉîÈëdz³öµØ³ÊÏÖ³ö»ñÒæ·çÏÕÆÀ¹ÀµÄ˼·¡£ÎҴӴ˴ογÌÖÐ×î´óµÄ»ñÒæÊÇ£¬½«Ö®Ç°µÄ¹¤×÷˼·Öð½¥ÊáÀí³öÏà¶ÔÃ÷È·µÄ¿ò¼Ü£¬¶ÔÖ®ºóµÄ¹¤×÷»áÓкܴóµÄ°ïÖú£¡ÕâÃſεĿª·¢£¬Æä¼ÛÖµ²»½ö½öÔÚÓÚ¿ÎÌÃÉÏ·ÖÏíµÄ֪ʶ£¬¸üÔÚÓÚ´ø¸ø´ó¼ÒµÄ˼ά·½Ê½ºÍ˼¿¼·½Ïò£¡¸Ðл¸÷λµ¼Ê¦µÄÓÃÐÄÉè¼ÆºÍÇãÇéͶÈ룡

¡¡¡¡ÀõÑÞ±ò£¨°Ù¼ÃÉñÖÝÒ©ÕþÊÂÎñ²¿Chief of Staff and Director of RPM£©£ºÒ©ÎïÑз¢µÄ»ñÒæ·çÏÕÆÀ¼ÛÊÇÒ»¸ö³ÖÐøµÄ¡¢¶¯Ì¬µÄ¹ý³Ì¡£ÓÿÆѧµÄ¡¢¿Í¹ÛµÄ¡¢ÏµÍ³µÄ˼¿¼¿ò¼ÜÈ¥ÆÀ¼Û£¬ÓÐÖúÓÚ¼à¹Ü»ú¹¹ºÍÉê°ì·½ÔÚÕû¸ö²úÆ·ÉúÃüÖÜÆÚÄÚ¶Ô²úÆ·Öð½¥ÓÅ»¯µÄ¹ÜÀí¡£