SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product|veterinary drug
- achoimre de thoradh saoráil faisnéise Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Ní féidir a mheas go soláthraítear faisnéis leordhóthanach i dtuarascálacha poiblí ar mheasúnuithe ná achoimrí de thoradh saoráil faisnéise, cé is moite den tuarascáil ar an measúnú arna foilsiú ag an nGníomhaireacht tar éis measúnú a dhéanamh ar iarratas le haghaidh uasteorainneacha iarmhar a bhunú, a bhféadfar í a úsáid mar litríocht ar bhealach iomchuí, go háirithe le haghaidh na dtástálacha sábháilteachta.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
- freedom of information summary | FOI summary
- en
- Definition summary that describes the safety and effectiveness information submitted by the drug sponsor to the FDA to support the approval of a New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) Reference "U.S. Food & Drug Administration (FDA). Freedom of Information (FOI) Summaries for Approved New Animal Drugs (16.2.2021)"
- Comment Under federal law, FDA must release this information after the agency approves the application. The FOI Summary provides the public with a summary of the information that FDA used to determine that the NADA or ANADA met the requirements for approval. Studies that the drug sponsor submitted to support the safety and effectiveness of the drug in the target animal species are summarized in the FOI Summary. For a drug for a food-producing species, the FOI Summary also includes summaries of human food safety studies that the sponsor submitted to demonstrate that food products made from treated animals are safe for people to eat.