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[all meeting types are free of charge] [all meeting types are free of charge] [all meeting types are free of charge] FDA:§K¶O §K¶O §K¶O FDA:§K¶O §K¶O §K¶O FDA:§K¶O §K¶O §K¶O -------------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2022/9/4 ¤W¤È 06:33:17²Ä 2371 ½g¦^À³ °ê¹©pre-eua meeting(eCTD Sequence Number:0025 )¡C eCTD Sequence Number´N¬OCDERµo¥Xªº¤å¥ó¦¬µo®×¸¹¡C FDA does not charge a fee for submitting an EUA request (or pre-EUA request)--->FDA¤£¦¬¨ú´£¥æEUA ½Ð ¨D¡]©Î EUA «e½Ð¨D¡^ªº¶O¥Î¡C pre-EUA requestÂkÄÝ©óType B meeting¡A¬OFDA[§K¶O]¬°¨üCDER©MCBERºÊºÞªºÃÄ«~¶}µo°Ó´£¨Ñ¥¿¦¡«Øijªº½dÃ¥! ---------------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2022/8/11 ¤U¤È 07:43:09²Ä 2311 ½g¦^À³ ¥Ó½ÐPRE-EUA meeting»PEUAnªá«Ü¦h¿ú¶Ü? (FDA:§K¶O §K¶O §K¶O) FDA§K¶O¬°¨üCDER©MCBERºÊºÞªºÃÄ«~¶}µo°Ó´£¨Ñ¥¿¦¡«Øij ¸ê®Æ¶}ªù¨£¤s¼gµÛ:FDA offers formal advice at no cost to developers of medicines regulated by both [CDER ]and CBER, with the aim of supporting medicinal product development from Phase 1 through to rketing. |
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¤§«e¤]¦³°Ý¹L¥Í§Þ·~ªB¤Í³o°ÝÃD¡A¦¬Áʦn¹³¬O©MENDOºX¤Uªº¤l¤½¥qñªº¡A¤£½T©w°]°È¤Wªº¾Þ§@¬O«ç¼Ë? ·Q»¡¬°¤°»ò¤£©M·sģñ?? ©ï·Lªº¾Þ§@¥u¯à»¡¨S¤ºÀ`§Ú¬O¤£¤Ó·Q«H ¤S¬O¤@Ó©M¦w¥Í¤@¼Ë¤jªÑªF±j¦l¤pªÑªF ====================================== Endo ¦]Àn¤ùÃþ¤îµhÃÄ Opana ER ©x¥q½ßÀvª÷ÃBÃe¤j¦Ò¼{¯}²£¥Ó½Ð¡A¥x·LÅ骺 TLC599 ±ÂÅv·|¤£·|¯}§½¡H With opioid litigation looming and $8B in debt, Endo looking at bankruptcy play: WSJ ¥X³B¡G www.fiercepharma.com/pharma/endo-headed-bankruptcy-other-opioid-crisis-litigants-purdue-and-mallinckrodt-wsj |
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