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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.
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
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The EMA validated the Marketing Authorization Application (MAA) for Kanuma and granted the company's request for accelerated assessment. Synageva's other pipeline programs consisted of protein therapeutic programs for rare diseases with unmet medical need at various stages of development, including a Phase 1/2 trial with its second, first-mover ...
Manufacturers that do submit a PMTA to the FDA by the May 14, 2022 deadline can continue marketing their products until July 13, 2022, after which time the products must be removed from retail stores unless the FDA has issued a PMTA marketing authorization order by the July 13, 2022 deadline date. [11] [12]
A former NASA commander has revealed that while piloting his private plane in Texas last summer he nearly had a collision with two mysterious “metallic, spherical orbs.” Astronaut Leroy Chiao ...