Guidance Documents definition
Examples of Guidance Documents in a sentence
All Guidance Documents identified herein are incorporated herein in their entirety for all purposes.
Keep all Inventory which constitutes Product in good and marketable condition, free from material defects and otherwise keep all Inventory which constitutes Product in material compliance with all applicable FDA Laws, FDA Good Manufacturing Practices, FDA Good Clinical Practice, FDA Good Laboratory Practices and FDA Guidance Documents, as applicable.
Sponsor shall (a) track and collect financial disclosure information from all “clinical investigators” involved in each Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.
Company shall (a) track and collect financial disclosure information from all “clinical investigators” involved in the Study and (b) prepare and submit the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.
The Party conducting a Clinical Study under a Right of Reference shall (a) track and collect financial disclosure information from all “clinical investigators” involved in such Clinical Study for such Program and (b) prepare and submit the certification or disclosure of the same in accordance with all applicable Law, including Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents.
Amendments to decrease or increase the subaward, to add or delete an Activity as allowed by the Guidance Documents, to extend the term of the Contract, and/or to make other substantial changes to the Contract may be made only by written agreement of the Parties under the formal Amendment process outlined below, except that, upon completion of the Project, the GLO shall issue a closeout letter pursuant to Section 2.03.
Certain tariff and generation interconnection types are outside the provisions of PUC Proceeding No. 16AL-0048E and are not covered in the Guidance Documents.
For an Active Material, this work will be defined and mutually agreed upon based on applicable Comparability Protocols, FDA Guidance Documents, and commitments made to a Regulatory Agency.
Additionally, Seller certifies that it conducts all operations in accordance with, and all Goods are produced under appropriate food safety and security protocols that comply with Hazard Analysis Critical Control Point requirements as well as applicable Canadian Food Inspection Agency Guidance Documents, the Safe Food for Canadians Act, the Marine Transportation Security Act, and the U.S. Food Safety Modernization Act.
Templates are supplied in Word .docx and Guidance Documents / Procedures in .PDF format.