FDA Regulated Product definition

FDA Regulated Product means any product or component including, without limitation, any medical device, that is studied, used, held or offered for sale for human research or investigation or clinical use.

FDA Regulated Product means and includes any of Issuer’s approved products, product candidates, or any components thereof that are subject to the FDCA and other Laws administered by the FDA.

FDA Regulated Product means any drug, medical device or combination product produced, sold, distributed or marketed by the Company or any of its Subsidiaries as of the date hereof that is or is required to be cleared or approved (including approval for research, investigation or clinical use) by the FDA and that is studied, used, held or offered for sale for human use, including for human research or investigation or clinical use.

Examples of FDA Regulated Product in a sentence

• FDA is announcing the availability of a draft guidance for industry entitled ‘‘Considering Whether an FDA- Regulated Product Involves the Application of Nanotechnology’’.

• Civil society organizations can also intervene to formulate policies to protect against workplace sexual harassment.Another intervention would be to encourage women to self-organize to further pressure administrations of news organizations to address gender disparities.

• IdentifySensors shall be responsible for reporting to each relevant Regulatory Agency all Complaints and adverse events relating to a Product that are required to be reported under the FDA Regulated Product quality management system requirements of ISO 13485, or other applicable agency reporting regulations.

• The Issuer has disclosed to the Purchaser any and all currently unresolved material complaints and other notices, actions, or Orders relating to any alleged lack of safety, efficacy, regulatory compliance, or any other allegations of any violation of any applicable Laws, or Order of any court or competent tribunal, by the Issuer or any of its Affiliates, or for any FDA Regulated Product that, either individually or in the aggregate, may result in a Material Adverse Effect.

• Issuer further represents that it has followed all material aspects of its standard operating procedures with respect to monitoring all third party vendors and suppliers, and maintaining the supply chain of the components of the FDA Regulated Product.

More Definitions of FDA Regulated Product

FDA Regulated Product means and includes any product or component that is subject to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. and its implementing regulations and/or other laws administered by the FDA.

FDA Regulated Product means and include any product or component that is cleared or approved by the FDA for sale for human use.

FDA Regulated Product shall have the meaning ascribed to such term in Section 3.1(ll).

FDA Regulated Product means each existing Company platform, program, product, product candidate or service subject to regulation by the FDA under Healthcare Regulatory Laws or any other comparable Law including (i) approved and investigational drugs, biological products, medical devices (including in vitro diagnostic tests and laboratory developed tests), and combination products and any raw materials or components of such drugs, biological products, medical devices, or combination products; and (ii) any products or services used in the design, monitoring, and control of manufacturing processes and facilities that are subject to Healthcare Regulatory Laws, including Current Good Manufacturing Practice regulations and/or Quality System regulations.

FDA Regulated Product means any drug, medical device or combination product produced, sold, distributed or marketed by the Company as of the date of this Agreement, that is or is required to be cleared or approved (including approval for research, investigation or clinical use) by the FDA, and that is studied, used, held or offered for sale for human use, including for human research or investigation or clinical use (provided that the term FDA Regulated Product shall not include INFASURF, which was marketed by the Company pursuant to the co-promotion agreement by and between Forest Laboratories, Inc. and the Company.

FDA Regulated Product means any product or component that is studied, used held or offered for sale for human or animal research or

FDA Regulated Product means any product or component including any medical device, that is studied, used, held or offered for sale for human research or investigation or clinical use.