Medical Product definition
Examples of Medical Product in a sentence
With respect to a Medical Product, any investigation in human subjects intended to discover or verify the clinical pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Products and/or to identify any adverse reactions to one or more Investigational Medicinal Products and/or to study absorption, distribution, metabolism and excretion of one or more Investigational Medicinal Products with the object of ascertaining its/their safety and/or efficacy.
In addition to the updates described in Section 5.7, KHK shall promptly provide DICERNA with (a) all Serious Adverse Event information relating to Licensed Products as such information is compiled or prepared by KHK in connection with the development or commercialization of any Licensed Product and, (b) copies of Periodic Safety Update Reports (Volume 9E of the Rule Covering Medical Product in the EU).
The Trial will be managed by CRO acting on behalf of Sponsor, for the clinical evaluation of Sponsor's Investigational Medical Product (hereafter “Trial Drug”) in accordance with the Protocol.
Neither the Company nor any Subsidiary of the Company has received any notice or other communication from the FDA or any other Governmental Authority (A) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Company or any Subsidiary of the Company or (B) otherwise alleging any violation applicable to any Medical Product of any applicable Law.
Sellers or their Affiliates have made all material filings with, or notifications to, all Governmental Authorities (including Medical Product Regulatory Authorities) required pursuant to Requirements of Law.