Agenzia italiana del farmaco

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U.S. Food and Drug Administration

agenzia italiana del farmaco

Statement of Authority and Confidentiality Commitment from The Agenzia Italiana Del Farmaco Not to Publicly Disclose Non-Public Information.

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Judgment of the Court First Chamber of 21 November Request for a preliminary ruling from the Consiglio di Stato. Digital reports Court Reports - general - 'Information on unpublished decisions' section. Bonichot, A. Arabadjiev, C. Fernlund Rapporteur and S.

FDA is further authorized under section c of the Federal Food, Drug, and Cosmetic Act 2 to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information. The Commissioner of Food and Drugs has certified AIFA as having the authority and demonstrated ability to protect trade secret information from disclosure. AIFA understands that some of the information it receives from FDA may include non-public information exempt from public disclosure, such as commercially confidential information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. AIFA understands that this non-public information is shared in confidence and that it is critical that AIFA maintains the confidentiality of exchanged non-public information. AIFA will protect such FDA-provided non-public information from public disclosure to the same extent that it will protect non-public information provided to it directly by FDA. The parties therefore intend to strengthen and give continuity to their collaboration.



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The service is active through the free number or it can be reached by post, fax and email., FDA is authorized under 21 C. FDA is further authorized under section c of the Federal Food, Drug, and Cosmetic Act 2 to share with a foreign government, as it deems appropriate and under limited circumstances, certain types of trade secret information.

Clinical Trials

SuRe Info Introduction Value of using different search appr Service providers and search interfaces Strategy development Search filters Other limits Peer reviewing search strategies Documenting and reporting Health problem and current use Description and technical characteristics Safety Diagnostic accuracy Clinical effectiveness Costs and economic evaluation Ethical analysis Organizational aspects Legal aspects Qualitative research Appraisals catalogue. Italian Medicines Agency. World area:. Is member of:. References on the country:.

In Italy the clinical trials are regulated by a legislative decree , entered into force in January Decreto legislativo 24 giugno , n. The above mentioned decree has integrally implemented the European directive and has also anticipated a few additional provisions issued in order to better regulate the responsibility and the role of the Ethics Committees and to give instructions about the type of information to be submitted through the database of the Osservatorio Nazionale della Sperimentazione Clinica OsSC - National Monitoring Centre of Clinical Trials. The annual number of clinical trials in Italy since has steadily grown. The submission of the clinical trial application data and supporting documents must be done through theOsSC Database. The sponsor must submit these data mainly in Italian except for free text core data set, where English language is required. For further details, please consult the Help section.

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3 thoughts on “Agenzia italiana del farmaco

  1. Agenzia Italiana del Farmaco (AIFA). Alternate name: Italian Medicines Agency. Country: Italy. World area: Europe. The Italian Medicines Agency (AIFA) is the.

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