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A letter that a person may file with a court, as a precautionary measure, to explain to the court that they do not infringe a specific patent, and/or that they consider the patent to be invalid, in an attempt to prevent the court from granting any ex parte preliminary injunction to the patentee, if the patentee were to ask the court for ...
Letters patent take the form of an open letter from the monarch to a subject, although this is a legal fiction and they are in fact a royal decree made under the royal prerogative and are treated as statute law. [5] Letters patent do not require the consent of parliament. [6] Specific usage in Commonwealth realms outside the United Kingdom include:
The letters were intended to let manufacturers know how much work is needed on their applications. [1] Non-approval letters were rejections of a drug's application. [ 2 ] Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations , section 314.110.
Homologation (Greek homologeo, ὁμολογέω, "to agree") is the granting of approval by an official authority.This may be a court of law, a government department, or an academic or professional body, any of which would normally work from a set of rules or standards to determine whether such approval should be given.
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In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
Thesaurus Linguae Latinae. A modern english thesaurus. A thesaurus (pl.: thesauri or thesauruses), sometimes called a synonym dictionary or dictionary of synonyms, is a reference work which arranges words by their meanings (or in simpler terms, a book where one can find different words with similar meanings to other words), [1] [2] sometimes as a hierarchy of broader and narrower terms ...