{"id":109209,"date":"2026-06-24T00:14:04","date_gmt":"2026-06-23T22:14:04","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=109209"},"modified":"2026-06-23T13:42:37","modified_gmt":"2026-06-23T11:42:37","slug":"americka-agentura-chce-urychlit-schvalovani-leku-mene-dat-mene-testu","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2026\/06\/24\/americka-agentura-chce-urychlit-schvalovani-leku-mene-dat-mene-testu\/","title":{"rendered":"Americk\u00e1 agentura chce urychlit schvalov\u00e1n\u00ed l\u00e9k\u016f: M\u00e9n\u011b dat, m\u00e9n\u011b test\u016f"},"content":{"rendered":"
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FDA spou\u0161t\u00ed \u201eOperaci TrialBlazer\u201c, kter\u00e1 m\u00e1 urychlit schvalov\u00e1n\u00ed experiment\u00e1ln\u00edch l\u00e9k\u016f.<\/span><\/strong><\/h4>\n

Podle agentury mohou firmy zkr\u00e1tit dobu v\u00fdvoje a\u017e o jeden rok, m\u00e9n\u011b se spol\u00e9hat na testov\u00e1n\u00ed na zv\u00ed\u0159atech a uv\u00e1d\u011bt produkty na trh rychleji s men\u0161\u00edm mno\u017estv\u00edm dat.<\/span><\/strong><\/p>\n

\u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) ozn\u00e1mil<\/span><\/a>\u00a0rozs\u00e1hlou novou iniciativu\u00a0, jej\u00edm\u017e c\u00edlem je urychlit cestu experiment\u00e1ln\u00edch l\u00e9k\u016f z laborato\u0159e do klinick\u00fdch studi\u00ed na lidech a nakonec ke schv\u00e1len\u00ed. Iniciativa nasti\u0148uje opat\u0159en\u00ed, jejich\u017e c\u00edlem je zkr\u00e1tit dobu v\u00fdvoje, sn\u00ed\u017eit informa\u010dn\u00ed po\u017eadavky, sn\u00ed\u017eit z\u00e1vislost na tradi\u010dn\u00edm testov\u00e1n\u00ed na zv\u00ed\u0159atech a urychlit cestu na trh.<\/span><\/p>\n

Nov\u00e1 iniciativa FDA s n\u00e1zvem \u201eOperace TrialBlazer\u201c pokr\u00fdv\u00e1 cel\u00fd proces v\u00fdvoje l\u00e9\u010div \u2013 od nejran\u011bj\u0161\u00edch f\u00e1z\u00ed v\u00fdvoje a\u017e po klinick\u00e9 studie prov\u00e1d\u011bn\u00e9 za \u00fa\u010delem z\u00edsk\u00e1n\u00ed schv\u00e1len\u00ed FDA.<\/span><\/p>\n

Zat\u00edmco agentura prezentuje toto \u00fasil\u00ed jako modernizaci, samotn\u00e9 dokumenty FDA opakovan\u011b popisuj\u00ed st\u00e1vaj\u00edc\u00ed po\u017eadavky, term\u00edny a testovac\u00ed postupy jako p\u0159ek\u00e1\u017eky, kter\u00e9 zpomaluj\u00ed v\u00fdvoj produkt\u016f.<\/span><\/p>\n

\u00da\u0159ad uv\u00e1d\u00ed, \u017ee iniciativa sleduje n\u00e1sleduj\u00edc\u00ed c\u00edle:<\/span><\/p>\n

\u201eUrychlit a modernizovat klinick\u00fd v\u00fdzkum v cel\u00e9m spektru v\u00fdvoje l\u00e9\u010div \u2013 od f\u00e1ze IND (Investigational New Drug) a\u017e po kl\u00ed\u010dov\u00e9 studie v pozdn\u00edch st\u00e1di\u00edch.\u201c<\/span><\/em><\/p>\n

Jednodu\u0161e \u0159e\u010deno: FDA hled\u00e1 zp\u016fsoby, jak rychleji dostat l\u00e9ky z f\u00e1ze v\u00fdvoje k hum\u00e1nn\u00edmu pou\u017eit\u00ed.<\/span><\/p>\n

Tento krok p\u0159ich\u00e1z\u00ed jen n\u011bkolik dn\u00ed pot\u00e9, co Poradn\u00ed v\u00fdbor pro vakc\u00edny a souvisej\u00edc\u00ed biologick\u00e9 produkty (VRBPAC) americk\u00e9ho \u00da\u0159adu pro kontrolu potravin a l\u00e9\u010div (FDA)\u00a0<\/span>jednomysln\u011b rozhodl<\/span><\/a>\u00a0, \u017ee \u201ev\u00fdhody\u201c experiment\u00e1ln\u00ed mRNA vakc\u00edny proti ch\u0159ipce od spole\u010dnosti Moderna, mFlusiva (mRNA-1010), \u201ep\u0159eva\u017euj\u00ed nad riziky\u201c, co\u017e p\u0159ipravuje cestu k mo\u017en\u00e9mu schv\u00e1len\u00ed FDA pro dosp\u011bl\u00e9 ve v\u011bku 50 let a star\u0161\u00ed.<\/span><\/p>\n

A to i p\u0159esto, \u017ee vlastn\u00ed studie f\u00e1ze 3 spole\u010dnosti Moderna potvrdila, \u017ee vakc\u00edna zp\u016fsobila p\u0159ibli\u017en\u011b \u0161estkr\u00e1t v\u00edce z\u00e1va\u017en\u00fdch vedlej\u0161\u00edch \u00fa\u010dink\u016f ne\u017e standardn\u00ed d\u00e1vky vakc\u00edn proti ch\u0159ipce, a z\u00e1rove\u0148 dos\u00e1hla absolutn\u00edho sn\u00ed\u017een\u00ed rizika o m\u00e9n\u011b ne\u017e jeden procentn\u00ed bod (<1 %).<\/span><\/p>\n

\u010clenov\u00e9 Kongresu varovali, \u017ee FDA \u201enedodr\u017euje d\u016fle\u017eit\u00e9 feder\u00e1ln\u00ed bezpe\u010dnostn\u00ed po\u017eadavky na ochranu sv\u00fdch zam\u011bstnanc\u016f a ve\u0159ejnosti a tak\u00e9 neup\u0159ednost\u0148uje kvalitu v\u011bdeck\u00fdch \u00fadaj\u016f poskytovan\u00fdch laborato\u0159emi FDA\u201c.<\/span><\/p>\n

Tento v\u00fdvoj vyvol\u00e1v\u00e1 ot\u00e1zku, pro\u010d FDA sou\u010dasn\u011b urychluje schvalov\u00e1n\u00ed l\u00e9k\u016f, zat\u00edmco je obvi\u0148ov\u00e1na z ji\u017e takov\u00e9ho nespln\u011bn\u00ed z\u00e1kladn\u00edch bezpe\u010dnostn\u00edch po\u017eadavk\u016f.<\/span><\/p>\n

M\u016f\u017eete\u00a0<\/span>kontaktovat FDA zde<\/span><\/a>\u00a0.<\/span><\/p>\n

Rychlej\u0161\u00ed dod\u00e1n\u00ed v\u00edce l\u00e9k\u016f v\u00edce lidem<\/span><\/strong><\/h3>\n

Jedn\u00edm z nejv\u00fdznamn\u011bj\u0161\u00edch aspekt\u016f nov\u00e9ho ozn\u00e1men\u00ed je navrhovan\u00fd pilotn\u00ed program pro urychlen\u00e9 schvalov\u00e1n\u00ed nov\u00fdch hodnocen\u00fdch l\u00e9\u010div.<\/span><\/p>\n

Podle FDA:<\/span><\/p>\n

\u201eNavrhovan\u00fd pilotn\u00ed program pro zrychlen\u00e9 aplikace IND by jako partnery zahrnoval \u0161pi\u010dkov\u00e9 americk\u00e9 v\u00fdzkumn\u00e9 instituce, aby se zkr\u00e1tila doba od identifikace l\u00e9ku a\u017e po prvn\u00ed klinickou studii na lidech.\u201c<\/span><\/em><\/p>\n

Tento c\u00edl ponech\u00e1v\u00e1 jen mal\u00fd prostor pro chybnou interpretaci.<\/span><\/p>\n

Agentura otev\u0159en\u011b hled\u00e1 zp\u016fsoby, jak zkr\u00e1tit dobu mezi identifikac\u00ed kandid\u00e1tn\u00edho l\u00e9ku a jeho pod\u00e1n\u00edm lidem.<\/span><\/p>\n

M\u00e9n\u011b dat za krat\u0161\u00ed dobu, ne v\u00edce dat za del\u0161\u00ed dobu.<\/span><\/strong><\/h3>\n

FDA se tak\u00e9 zam\u011b\u0159uje na mno\u017estv\u00ed informac\u00ed, kter\u00e9 spole\u010dnosti shroma\u017e\u010fuj\u00ed p\u0159ed testov\u00e1n\u00edm produkt\u016f na lidech.<\/span><\/p>\n

Podle FDA:<\/span><\/p>\n

\u201eV minulosti n\u011bkter\u00e9 spole\u010dnosti p\u0159edlo\u017eily v\u00edce dat, ne\u017e bylo v t\u00e9to f\u00e1zi v\u00fdvojov\u00e9ho procesu po\u017eadov\u00e1no, co\u017e vedlo ke zbyte\u010dn\u00e9 pr\u00e1ci a zpo\u017ed\u011bn\u00ed zaveden\u00ed slibn\u00fdch terapi\u00ed do ran\u00fdch klinick\u00fdch studi\u00ed.\u201c<\/span><\/em><\/p>\n

\u00da\u0159ad uv\u00e1d\u00ed, \u017ee spole\u010dnosti \u201eby m\u011bly shroma\u017e\u010fovat a p\u0159en\u00e1\u0161et pouze data, kter\u00e1 jsou skute\u010dn\u011b pot\u0159ebn\u00e1\u201c.<\/span><\/p>\n

Podle FDA:<\/span><\/p>\n

\u201eZam\u011b\u0159en\u00edm se v\u00fdhradn\u011b na po\u017eadavky relevantn\u00ed pro danou f\u00e1zi mohou firmy u\u0161et\u0159it 6 a\u017e 12 m\u011bs\u00edc\u016f \u010dasu na v\u00fdvoj.\u201c<\/span><\/em><\/p>\n

To znamen\u00e1, \u017ee FDA o\u010dek\u00e1v\u00e1, \u017ee se v tomto procesu m\u016f\u017ee u\u0161et\u0159it a\u017e rok, ne\u017e se produkty p\u0159esunou do dal\u0161\u00ed f\u00e1ze v\u00fdvoje.<\/span><\/p>\n

Pro Ameri\u010dany, kte\u0159\u00ed se ji\u017e nyn\u00ed domn\u00edvaj\u00ed, \u017ee l\u00e9ky jsou uvol\u0148ov\u00e1ny p\u0159\u00edli\u0161 rychle, toto ozn\u00e1men\u00ed vyvol\u00e1v\u00e1 z\u0159ejmou ot\u00e1zku: Jak\u00e1 bezpe\u010dnostn\u00ed opat\u0159en\u00ed, studie, recenze nebo informace m\u016f\u017ee FDA vynechat, aby zkr\u00e1tila lh\u016ftu o \u0161est a\u017e dvan\u00e1ct m\u011bs\u00edc\u016f?<\/span><\/p>\n

Zrychlen\u00fd proces schvalov\u00e1n\u00ed FDA<\/span><\/strong><\/h3>\n

Snahy o urychlen\u00ed procesu pokra\u010duj\u00ed i \u200b\u200bv samotn\u00e9m schvalovac\u00edm \u0159\u00edzen\u00ed.<\/span><\/p>\n

Z\u00e1rove\u0148 FDA revidovala pokyny, kter\u00e9 upravuj\u00ed, jak\u00e9 d\u016fkazy mohou spole\u010dnosti pou\u017e\u00edt k podpo\u0159e schv\u00e1len\u00ed.<\/span><\/p>\n

Podle \u00fa\u0159adu:<\/span><\/p>\n

\u201eFDA revidoval tyto pokyny, aby objasnil okolnosti, za kter\u00fdch se v\u00fdvoj\u00e1\u0159i l\u00e9\u010div mohou spol\u00e9hat na p\u0159\u00edsnou, adekv\u00e1tn\u00ed a dob\u0159e kontrolovanou kl\u00ed\u010dovou klinickou studii a potvrzuj\u00edc\u00ed d\u016fkazy, kter\u00e9 poskytnou podstatn\u00e9 d\u016fkazy o \u00fa\u010dinnosti pro schv\u00e1len\u00ed l\u00e9ku.\u201c<\/span><\/em><\/p>\n

P\u0159ij\u00edmac\u00ed \u0159\u00edzen\u00ed je nejd\u016fle\u017eit\u011bj\u0161\u00edm studiem, na kter\u00e9m se zakl\u00e1daj\u00ed rozhodnut\u00ed o p\u0159ijet\u00ed.<\/span><\/p>\n

Revidovan\u00e9 pokyny roz\u0161i\u0159uj\u00ed okolnosti, za kter\u00fdch m\u016f\u017ee b\u00fdt p\u0159\u00edpravek schv\u00e1len na z\u00e1klad\u011b jedin\u00e9 registra\u010dn\u00ed studie ve spojen\u00ed s dal\u0161\u00edmi d\u016fkazy.<\/span><\/p>\n

Podle FDA mohou tyto p\u0159\u00edstupy:<\/span><\/p>\n

\u201eAby se sn\u00ed\u017eila duplicitn\u00ed infrastruktura, optimalizoval sb\u011br dat a urychlila se tvorba d\u016fkaz\u016f pot\u0159ebn\u00fdch pro rozhodov\u00e1n\u00ed dozorov\u00fdch org\u00e1n\u016f.\u201c<\/span><\/em><\/p>\n

Z\u00e1v\u011br<\/span><\/strong><\/h3>\n

Dokumenty odhaluj\u00ed koordinovanou iniciativu FDA, jej\u00edm\u017e c\u00edlem je identifikovat v\u0161echny f\u00e1ze procesu v\u00fdvoje l\u00e9\u010div, kter\u00e9 zpo\u017e\u010fuj\u00ed v\u00fdvoj produkt\u016f, a prozkoumat, zda lze tyto kroky zkr\u00e1tit, zjednodu\u0161it, nahradit nebo zcela eliminovat.<\/span><\/p>\n

Jazyk pou\u017eit\u00fd v cel\u00e9m ozn\u00e1men\u00ed je v\u00fdmluvn\u00fd.<\/span><\/p>\n

FDA opakovan\u011b pou\u017e\u00edv\u00e1 term\u00edny jako \u201eurychlit\u201c, \u201ezkr\u00e1tit\u201c, \u201eomezit\u201c, \u201ezefektivnit\u201c, \u201eflexibiln\u00ed\u201c a \u201eu\u0161et\u0159it \u010das v\u00fdvoje\u201c.<\/span><\/p>\n

Snad nejjasn\u011bj\u0161\u00edm p\u0159izn\u00e1n\u00edm ze strany \u00fa\u0159adu je jeho prohl\u00e1\u0161en\u00ed, \u017ee revidovan\u00e9 po\u017eadavky by mohly sponzor\u016fm u\u0161et\u0159it \u201e6 a\u017e 12 m\u011bs\u00edc\u016f \u010dasu na v\u00fdvoj\u201c.<\/span><\/p>\n

Pro kritiky, kte\u0159\u00ed se ji\u017e nyn\u00ed domn\u00edvaj\u00ed, \u017ee farmaceutick\u00e9 produkty jsou usp\u011bchan\u00e9 ve v\u00fdvoji bez \u0159\u00e1dn\u00e9ho dlouhodob\u00e9ho posouzen\u00ed bezpe\u010dnosti, je nepravd\u011bpodobn\u00e9, \u017ee by toto ozn\u00e1men\u00ed bylo vn\u00edm\u00e1no jako zp\u0159\u00edsn\u011bn\u00ed standard\u016f, ale sp\u00ed\u0161e jako vl\u00e1dn\u00ed iniciativa s c\u00edlem urychlit zav\u00e1d\u011bn\u00ed experiment\u00e1ln\u00edch produkt\u016f.<\/span><\/p>\n

Od Jona Fleetwooda<\/span><\/em><\/strong><\/p>\n<\/div>\n<\/div>\n

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Zdroj<\/span><\/a><\/span><\/h3>\n

 <\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

FDA spou\u0161t\u00ed \u201eOperaci TrialBlazer\u201c, kter\u00e1 m\u00e1 urychlit schvalov\u00e1n\u00ed experiment\u00e1ln\u00edch l\u00e9k\u016f. Podle agentury mohou firmy zkr\u00e1tit…<\/p>\n","protected":false},"author":2,"featured_media":109210,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1088,11145,7310,37],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/109209"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=109209"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/109209\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/109210"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=109209"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=109209"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=109209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}