{"id":7647,"date":"2019-04-15T12:58:41","date_gmt":"2019-04-15T05:58:41","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=7647"},"modified":"2019-04-19T13:05:54","modified_gmt":"2019-04-19T06:05:54","slug":"fda-yeu-cau-thay-doi-thong-tin-an-toan-tren-nhan-thuoc-addyi-flibanserin","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/fda-yeu-cau-thay-doi-thong-tin-an-toan-tren-nhan-thuoc-addyi-flibanserin\/","title":{"rendered":"FDA: Y\u00eau c\u1ea7u thay \u0111\u1ed5i th\u00f4ng tin an to\u00e0n tr\u00ean nh\u00e3n thu\u1ed1c Addyi (flibanserin)"},"content":{"rendered":"

$\"Addyi\"$ <\/p>\n

\u201cFDA gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng th\u00f4ng tin an to\u00e0n m\u1edbi nh\u1ea5t v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng thu\u1ed1c k\u00ea \u0111\u01a1n \u0111\u01b0\u1ee3c ph\u1ea3n \u00e1nh ch\u00ednh x\u00e1c trong nh\u00e3n s\u1ea3n ph\u1ea9m, gi\u00fap c\u00e1n b\u1ed9 y t\u1ebf v\u00e0 b\u1ec7nh nh\u00e2n c\u00f3 th\u1ec3 \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb s\u00e1ng su\u1ed1t nh\u1ea5t\u201d, Julie Beitz, Gi\u00e1m \u0111\u1ed1c V\u0103n ph\u00f2ng \u0110\u00e1nh gi\u00e1 Thu\u1ed1c s\u1ed1 III t\u1ea1i Trung t\u00e2m \u0110\u00e1nh gi\u00e1 Thu\u1ed1c v\u00e0 Nghi\u00ean c\u1ee9u Thu\u1ed1c m\u1edbi c\u1ee7a FDA. \u201cCh\u00fang t\u00f4i nh\u1eadn th\u1ea5y r\u1eb1ng ph\u1ee5 n\u1eef mu\u1ed1n ti\u1ebfp c\u1eadn c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb r\u1ed1i lo\u1ea1n ch\u1ee9c n\u0103ng t\u00ecnh d\u1ee5c n\u1eef v\u00e0 ch\u00fang t\u00f4i cam k\u1ebft gi\u00fap \u0111\u1ea3m b\u1ea3o c\u00e1c thu\u1ed1c \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t l\u00e0 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 khi \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh v\u00e0 h\u1ed7 tr\u1ee3 cho s\u1ef1 ph\u00e1t tri\u1ec3n c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi cho r\u1ed1i lo\u1ea1n ch\u1ee9c n\u0103ng t\u00ecnh d\u1ee5c n\u1eef\u201d.<\/p>\n

T\u1ea1i th\u1eddi \u0111i\u1ec3m ph\u00ea duy\u1ec7t, FDA \u0111\u00e3 xem x\u00e9t d\u1eef li\u1ec7u bao g\u1ed3m m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p li\u00ean quan \u0111\u1ebfn h\u1ea1 huy\u1ebft \u00e1p nghi\u00eam tr\u1ecdng v\u00e0 ng\u1ea5t x\u1ec9u khi u\u1ed1ng Addyi c\u00f9ng v\u1edbi r\u01b0\u1ee3u. Do \u0111\u00f3, nh\u00e3n thu\u1ed1c Addyi c\u1ea7n b\u1ed5 sung g\u00f3c c\u1ea3nh b\u00e1o theo y\u00eau c\u1ea7u c\u1ee7a FDA, trong \u0111\u00f3 n\u00eau r\u00f5 r\u1eb1ng ph\u1ee5 n\u1eef \u0111ang \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Addyi c\u1ea7n tr\u00e1nh u\u1ed1ng r\u01b0\u1ee3u. FDA c\u0169ng y\u00eau c\u1ea7u m\u1ed9t chi\u1ebfn l\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u00e0 gi\u1ea3m thi\u1ec3u r\u1ee7i ro (REMS), y\u00eau c\u1ea7u REMS ph\u1ea3i t\u01b0 v\u1ea5n v\u1ec1 nguy c\u01a1 t\u1ee5t huy\u1ebft \u00e1p v\u00e0 ng\u1ea5t x\u1ec9u t\u1edbi c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf k\u00ea \u0111\u01a1n Addyi v\u00e0 c\u00e1c nh\u00e0 thu\u1ed1c ph\u00e2n ph\u1ed1i Addyi v\u00e0 b\u1ec7nh nh\u00e2n. Ngo\u00e0i ra, FDA y\u00eau c\u1ea7u Sprout nghi\u00ean c\u1ee9u th\u00eam v\u1ec1 t\u01b0\u01a1ng t\u00e1c gi\u1eefa Addyi v\u00e0 r\u01b0\u1ee3u sau khi thu\u1ed1c n\u00e0y \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t.<\/p>\n

D\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c nghi\u00ean c\u1ee9u th\u1eed nghi\u1ec7m pha IV, FDA \u0111\u00e3 x\u00e1c \u0111\u1ecbnh r\u1eb1ng nh\u1eefng thay \u0111\u1ed5i ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u1ed1i v\u1edbi vi\u1ec7c d\u00e1n nh\u00e3n Addyi, \u0111\u1ec3 l\u00e0m r\u00f5 r\u1eb1ng v\u1eabn c\u00f2n r\u1ee7i ro v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng r\u01b0\u1ee3u khi \u0111ang d\u00f9ng thu\u1ed1c Addyi nh\u01b0ng kh\u00f4ng c\u1ea7n ph\u1ea3i tr\u00e1nh ho\u00e0n to\u00e0n. C\u1ee5 th\u1ec3, g\u00f3c c\u1ea3nh b\u00e1o, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, c\u1ea3nh b\u00e1o v\u00e0 ph\u00f2ng ng\u1eeba, v\u00e0 c\u00e1c ph\u1ea7n ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i trong nh\u00e3n thu\u1ed1c \u0111ang \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt \u0111\u1ec3 c\u1ea3nh b\u00e1o r\u1eb1ng ph\u1ee5 n\u1eef n\u00ean ng\u1eebng u\u1ed1ng r\u01b0\u1ee3u \u00edt nh\u1ea5t hai gi\u1edd tr\u01b0\u1edbc khi u\u1ed1ng Addyi v\u00e0o bu\u1ed5i t\u1ed1i ho\u1eb7c b\u1ecf qua li\u1ec1u Addyi v\u00e0o t\u1ed1i h\u00f4m \u0111\u00f3. Ph\u1ee5 n\u1eef kh\u00f4ng n\u00ean u\u1ed1ng r\u01b0\u1ee3u \u00edt nh\u1ea5t cho \u0111\u1ebfn bu\u1ed5is\u00e1ng sau bu\u1ed5i t\u1ed1i s\u1eed d\u1ee5ng Addyi.<\/p>\n

FDA \u0111ang ban h\u00e0nh l\u1ec7nh y\u00eau c\u1ea7u C\u00f4ng ty D\u01b0\u1ee3c ph\u1ea9m Sprout th\u1ef1c hi\u1ec7n nh\u1eefng thay \u0111\u1ed5i n\u00e0y v\u00ec FDA kh\u00f4ng th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c th\u1ecfa thu\u1eadn v\u1edbi c\u00f4ng ty n\u00e0y, h\u1ecd \u0111ang ti\u1ebfp t\u1ee5c y\u00eau c\u1ea7u lo\u1ea1i b\u1ecf g\u00f3c c\u1ea3nh b\u00e1o v\u00e0 ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh v\u1ec1 r\u01b0\u1ee3u ho\u00e0n to\u00e0n kh\u1ecfi nh\u00e3n s\u1ea3n ph\u1ea9m. FDA x\u00e1c \u0111\u1ecbnh, d\u1ef1a tr\u00ean vi\u1ec7c xem x\u00e9t c\u1ea9n th\u1eadn d\u1eef li\u1ec7u hi\u1ec7n c\u00f3, vi\u1ec7c x\u00f3a th\u00f4ng tin an to\u00e0n quan tr\u1ecdng n\u00e0y kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn, nh\u1eb1m m\u1ee5c \u0111\u00edch b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng.<\/p>\n

\u201cCh\u00fang t\u00f4i l\u00e0m vi\u1ec7c t\u00edch c\u1ef1c v\u1edbi c\u00e1c c\u00f4ng ty \u0111\u1ec3 th\u1ef1c hi\u1ec7n c\u1eadp nh\u1eadt nh\u00e3n thu\u1ed1c nh\u01b0ng \u0111\u00f4i khi kh\u00f4ng th\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c th\u1ecfa thu\u1eadn. Trong nh\u1eefng tr\u01b0\u1eddng h\u1ee3p hi\u1ebfm hoi \u0111\u00f3, ch\u1eb3ng h\u1ea1n nh\u01b0 v\u1edbi Addyi, ch\u00fang t\u00f4i c\u00f3 \u0111\u1ee7 th\u1ea9m quy\u1ec1n \u0111\u1ec3 bu\u1ed9c c\u00e1c c\u00f4ng ty th\u1ef1c hi\u1ec7n c\u00e1c thay \u0111\u1ed5i nh\u00e3n an to\u00e0n l\u00e0 r\u1ea5t quan tr\u1ecdng \u0111\u1ec3 s\u1eed d\u1ee5ng an to\u00e0n m\u1ed9t s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t. Ch\u00fang t\u00f4i \u0111ang th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng n\u00e0y v\u00ec tr\u00e1ch nhi\u1ec7m c\u1ee7a ch\u00fang t\u00f4i l\u00e0 gi\u00fap b\u1ea3o v\u1ec7 s\u1ef1 an to\u00e0n c\u1ee7a nh\u1eefng ng\u01b0\u1eddi d\u00f9ng thu\u1ed1c k\u00ea \u0111\u01a1n, trong \u0111\u00f3 bao g\u1ed3m gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ti\u1ebfp c\u1eadn th\u00f4ng tin c\u1eadp nh\u1eadt nh\u1ea5t v\u1ec1 c\u00e1c lo\u1ea1i thu\u1ed1c h\u1ecd d\u00f9ng\u201d Ti\u1ebfn s\u0129 Beitz cho bi\u1ebft.<\/p>\n

Quy\u1ebft \u0111\u1ecbnh c\u1ee7a FDA v\u1ec1 vi\u1ec7c ra l\u1ec7nh s\u1eeda \u0111\u1ed5i c\u00e1c c\u1ea3nh b\u00e1o v\u1ec1 Addyi v\u00e0 r\u01b0\u1ee3u, thay v\u00ec lo\u1ea1i b\u1ecf ho\u00e0n to\u00e0n c\u1ea3nh b\u00e1o v\u00e0 ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh \u0111\u00f3ng h\u1ed9p, d\u1ef1a tr\u00ean hai cu\u1ed9cnghi\u00ean c\u1ee9u h\u1eadu m\u00e3i .<\/p>\n

Trong th\u1eed nghi\u1ec7m pha IV theo y\u00eau c\u1ea7u c\u1ee7a FDA \u1edf nh\u1eefng ph\u1ee5 n\u1eef u\u1ed1ng Addyi v\u00e0 u\u1ed1ng r\u01b0\u1ee3u c\u00f9ng m\u1ed9t l\u00fac, c\u00e1c ph\u00e9p \u0111o huy\u1ebft \u00e1p t\u1eeb khi ph\u1ee5 n\u1eef l\u1ea7n \u0111\u1ea7u ti\u00ean n\u1eb1m xu\u1ed1ng t\u1edbikhi h\u1ecd \u0111\u1ee9ng l\u00ean \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n \u0111\u00fang v\u00e0 \u0111\u1ee7, m\u1eb7c d\u00f9 ph\u00e9p \u0111o n\u00e0y l\u00e0 r\u1ea5t quan tr\u1ecdng trong vi\u1ec7c x\u00e1c \u0111\u1ecbnh nguy c\u01a1 h\u1ea1 huy\u1ebft \u00e1p v\u00e0 ng\u1ea5t khi d\u00f9ng Addyi v\u00e0 r\u01b0\u1ee3u c\u00f9ng nhau. C\u1ee5 th\u1ec3,v\u1edbi th\u1ee7 nghi\u1ec7m tr\u00ean, FDA lo ng\u1ea1i r\u1eb1ng:<\/p>\n

M\u1eb7c d\u00f9 kh\u00f4ng c\u00f3 b\u00e1o c\u00e1o v\u1ec1 ng\u1ea5t ho\u1eb7c h\u1ea1 huy\u1ebft \u00e1p c\u1ea7n can thi\u1ec7p \u1edf c\u00e1c b\u1ec7nh nh\u00e2nn\u1eef trong th\u1eed nghi\u1ec7m, c\u00e1c bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba an to\u00e0n \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o th\u1eed nghi\u1ec7m n\u00e0y kh\u00f4ng cho ph\u00e9p \u0111\u00e1nh gi\u00e1 \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 nguy c\u01a1 n\u00e0y. V\u00ed d\u1ee5, ph\u1ee5 n\u1eef b\u1ecb huy\u1ebft \u00e1p th\u1ea5p khi n\u1eb1m ho\u1eb7c c\u00f3 c\u00e1c tri\u1ec7u ch\u1ee9ng li\u00ean quan \u0111\u1ebfn huy\u1ebft \u00e1p th\u1ea5p (nh\u01b0 ch\u00f3ng m\u1eb7t) kh\u00f4ng \u0111\u01b0\u1ee3c ph\u00e9p \u0111\u1ee9ng l\u00ean \u0111\u1ec3 \u0111o huy\u1ebft \u00e1p ho\u1eb7c ph\u1ea3i \u0111o huy\u1ebft \u00e1p nhi\u1ec1u l\u1ea7n trong khi n\u1eb1m cho \u0111\u1ebfn khi huy\u1ebft \u00e1p \u0111\u1ee7 cao \u0111\u1ec3 h\u1ecd \u0111\u1ee9ng l\u00ean m\u1ed9t c\u00e1ch an to\u00e0n. Do \u0111\u00f3, d\u1eef li\u1ec7u thu th\u1eadp \u0111\u01b0\u1ee3c t\u1eeb c\u00e1c ph\u00e9p \u0111o huy\u1ebft \u00e1p b\u1ecb thi\u1ebfu.<\/p>\n

Nhi\u1ec1u ph\u1ee5 n\u1eef \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c \u0111o huy\u1ebft \u00e1p khi h\u1ecd s\u1eed d\u1ee5ng \u0111\u1ed3ng th\u1eddi Addyi v\u00e0 r\u01b0\u1ee3u, khi ch\u1ec9 u\u1ed1ng r\u01b0\u1ee3u v\u00e0 khi ch\u1ec9 u\u1ed1ng Addyi.<\/p>\n

D\u1eef li\u1ec7u huy\u1ebft \u00e1p t\u1ea1i th\u1eddi \u0111i\u1ec3mn\u1ed3ng \u0111\u1ed9 thu\u1ed1c trong m\u00e1u cao nh\u1ea5t \u1edf nh\u1eefng ng\u01b0\u1eddi d\u00f9ng Addyi v\u1edbi r\u01b0\u1ee3u l\u00e0 d\u1eef li\u1ec7u b\u1ecb thi\u1ebfu nhi\u1ec1u nh\u1ea5t<\/p>\n

K\u1ebft qu\u1ea3 v\u1ec1 c\u00e1c b\u1eb1ng ch\u1ee9ng ch\u1ee9ng minhs\u1ef1 t\u01b0\u01a1ng t\u00e1c gi\u1eefa Addyi v\u00e0 r\u01b0\u1ee3u c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1 h\u1ea1 huy\u1ebft \u00e1p v\u00e0 ng\u1ea5t. V\u1edbi nh\u1eefng k\u1ebft qu\u1ea3 n\u00e0y, FDA ti\u1ebfp t\u1ee5c ban h\u00e0nh vi\u1ec7c b\u1ed5 sung thoing tin v\u00e0o g\u00f3c c\u1ea3nh b\u00e1o v\u00e0 ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh. B\u1ec7nh nh\u00e2n n\u1eef \u0111i\u1ec1u tr\u1ecb \u1edf nh\u00e0 s\u1ebd kh\u00f4ng c\u00f3 c\u00e1c bi\u1ec7n ph\u00e1p an to\u00e0n ho\u1eb7c nh\u1ea5t thi\u1ebft ph\u1ea3i \u0111\u01b0\u1ee3c ti\u1ebfp c\u1eadn v\u1edbi h\u1ed7 tr\u1ee3 ngay l\u1eadp t\u1ee9c n\u1ebfu h\u1ecd b\u1ecb h\u1ea1 huy\u1ebft \u00e1p ho\u1eb7c ng\u1ea5t, do \u0111\u00f3 h\u1ecd ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi c\u00e1c nguy c\u01a1nghi\u00eam tr\u1ecdng bao g\u1ed3m t\u00e9 ng\u00e3, tai n\u1ea1n v\u00e0 t\u1ed5n th\u01b0\u01a1ng c\u01a1 th\u1ec3.<\/p>\n

Trong c\u00e1c th\u1eed nghi\u1ec7m pha IV kh\u00e1c, k\u1ebft qu\u1ea3 cho th\u1ea5y nguy c\u01a1 h\u1ea1 huy\u1ebft \u00e1p v\u00e0 ng\u1ea5t nghi\u00eam tr\u1ecdng \u0111\u00e3 gi\u1ea3m khi ph\u1ee5 n\u1eef s\u1eed d\u1ee5ng lo\u1ea1i \u0111\u1ed3 u\u1ed1ng c\u00f3 c\u1ed3n ch\u1edd \u00edt nh\u1ea5t hai gi\u1edd tr\u01b0\u1edbc khi u\u1ed1ng Addyi. FDA \u0111\u00e3 t\u00ecm th\u1ea5y nh\u1eefng k\u1ebft qu\u1ea3 n\u00e0y \u0111\u1ee7 \u0111\u1ec3 h\u1ed7 tr\u1ee3 s\u1eeda \u0111\u1ed5i g\u00f3c c\u1ea3nh b\u00e1o v\u00e0 ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh c\u1ee7a Addyi v\u00e0 r\u01b0\u1ee3u kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ngc\u00f9ng l\u00fac (t\u1ee9c l\u00e0 kh\u00f4ng trong v\u00f2ng hai gi\u1edd).<\/p>\n

Addyi l\u00e0 m\u1ed9t ch\u1ea5t ch\u1ee7 v\u1eadn th\u1ee5 th\u1ec3 serotonin 1A v\u00e0 ch\u1ea5t \u0111\u1ed1i kh\u00e1ng th\u1ee5 th\u1ec3 serotonin 2A, nh\u01b0ng c\u01a1 ch\u1ebf c\u1ee7athu\u1ed1ctrong vi\u1ec7cc\u1ea3i thi\u1ec7n ham mu\u1ed1n t\u00ecnh d\u1ee5c v\u00e0c\u00e1c r\u1ed1i lo\u1ea1nli\u00ean quan v\u1eabn ch\u01b0a\u0111\u01b0\u1ee3c bi\u1ebft \u0111\u1ebfn. Addyi \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n m\u1ed7i ng\u00e0, tr\u01b0\u1edbc khi \u0111i ng\u1ee7 \u0111\u1ec3 gi\u00fap gi\u1ea3m nguy c\u01a1 c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 x\u1ea3y ra do h\u1ea1 huy\u1ebft \u00e1p, ng\u1ea5t v\u00e0 \u1ee9c ch\u1ebf h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng (nh\u01b0 bu\u1ed3n ng\u1ee7 v\u00e0 an th\u1ea7n). B\u1ec7nh nh\u00e2n n\u00ean ng\u1eebng \u0111i\u1ec1u tr\u1ecb sau t\u00e1m tu\u1ea7n n\u1ebfu b\u1ec7nh kh\u00f4ng c\u00f3 ti\u1ebfn tri\u1ec3n t\u1ed1t. C\u00e1c ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i ph\u1ed5 bi\u1ebfn nh\u1ea5t li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng Addyi l\u00e0 ch\u00f3ng m\u1eb7t, bu\u1ed3n ng\u1ee7,bu\u1ed3n n\u00f4n, m\u1ec7t m\u1ecfi, m\u1ea5t ng\u1ee7 v\u00e0 kh\u00f4 mi\u1ec7ng.<\/p>\n

\u0110\u1ea1o lu\u1eadt S\u1eeda \u0111\u1ed5i Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m n\u0103m 2007 \u0111\u00e3 cho ph\u00e9p FDA c\u00f3 th\u1ea9m quy\u1ec1n y\u00eau c\u1ea7u v\u00e0, khi c\u1ea7n thi\u1ebft, ra l\u1ec7nh thay \u0111\u1ed5i nh\u00e3n an to\u00e0n \u0111\u1ec3 c\u1eadp nh\u1eadt th\u00f4ng tin an to\u00e0n m\u1edbi v\u1ec1 thu\u1ed1c k\u00ea \u0111\u01a1n \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t. Vi\u1ec7c kh\u00f4ng \u0111\u00e1p \u1ee9ng v\u1edbiy\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn x\u1eed ph\u1ea1t h\u00e0nh ch\u00ednh v\u00e0 c\u00e1c h\u00e0nh \u0111\u1ed9ng th\u1ef1c thi b\u1ed5 sung bao g\u1ed3m thu gi\u1eef s\u1ea3n ph\u1ea9m v\u00e0 l\u1ec7nh c\u1ea5m. Sprout \u0111\u01b0\u1ee3c gia h\u1ea1n\u0111\u1ebfn ng\u00e0y 16 th\u00e1ng 4 n\u0103m 2019, \u0111\u1ec3 kh\u00e1ng c\u00e1o l\u1ec7nh ban h\u00e0nh n\u00e0y th\u00f4ng qua quy tr\u00ecnh gi\u1ea3i quy\u1ebft tranh ch\u1ea5p ch\u00ednh th\u1ee9c c\u1ee7a FDA.<\/p>\n

Ngu\u1ed3n: https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm635847.htm<\/a><\/p>\n

Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: \u0110\u1ed7 Thu Thanh – Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay – trung T\u00e2m C\u1ea3nh Gi\u00e1c D\u01b0\u1ee3c Qu\u1ed1c Gia.<\/p>\n

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