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[DOC File]Investigational New Drug (IND) Submission checklist
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The review division should be contacted or the FDA website can be searched for these documents. The first IND submission should capture all current pharmacology and toxicology information upon which the decision to proceed to study the product in humans was based, up through what is known when the IND is ready for submission.
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[DOC File]Regulatory Must-Take Value Submission Procedure
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Tariff section 4.6.10.3 also requires as part of the initial and annual process, the Generating Unit owner or operator must provide the CAISO and its Scheduling Coordinator, if the Scheduling Coordinator is a UDC or MSS, with an annual non-binding indicative Regulatory Must Take Generation usage profile.
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[DOC File]Auditing of Quality Systems of Medical Device ...
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The audit process applies to initial, surveillance and special audits. 11.1 Preparation. 11.1.1 Notification. Where permitted by the regulatory requirements, the manufacturer should be notified in advance that an audit is to be conducted. 11.1.2 Preview of quality system description
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[DOCX File]Home - The University of Alabama at Birmingham | UAB
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Regulatory Document Submission Process (Initial and continuous Submissions) Sponsor, CRO and Internal Audits. Required training. Site activation: investigator meeting. IND/IDE Development and Management . Drug/Device Storage, Accountability and Management.
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[DOCX File]Strategic Assessment of Electronic Submission Messaging ...
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The scope of this document is limited to premarket medical device submissions and secondary uses of regulatory submission data. The following topics are out of scope: Pharmaceutical and combination product submissions; and software solutions used to implement the exchange standard. ... For example, a submission for a manufacturing process ...
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[DOC File]Contractor Performance Assessment & Reporting System ...
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CPARS General Process Flow. Rating Definitions. Areas for Evaluation – Construction. The Assessing Official (AO) and AO Representative (AOR) will evaluate Contractor performance for this contract based on the following areas: ... 4 5 Adequacy of Initial Progress Schedule Adherence to Approved Schedule Resolution of Delays Submission of ...
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[DOCX File]SOP: Regulatory Review
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This procedure establishes the process to review IRB submissions for regulatory issues. This procedure begins when an IRB submission for a review or determination has been checked by office staff. This procedure ends when the has completed the review or an investigator has withdrawn the submission.
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[DOCX File]HUD | HUD.gov / U.S. Department of Housing and Urban ...
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Regulatory Authority: 24 CFR §§ 1003.400, 1003.401, 1003.402; Section I.A.1.b. of FY19/20 ICDBG Notice of Funding Availability (NOFA) 1) Criteria for Funding: With respect to applications for ICDBG-CARES grants and FY 2020 ICDBG Imminent Threat grants to address the COVID-19 crisis, the urgency and immediacy of the threat will be presumed.
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[DOCX File]DOD and HSRRB Specific Requirements
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Submission and Administrative Review Process . a. Do. D. research programs submit proposals selected for funding to the USAMR. D. C ORP HRPO for human subjects protection regulatory review. A . Proposal Submission Form, designed to facilitate the protocol review process, is also submitted for review. This submission form contains information ...
regulatory submission types

[DOCX File]Grant Application Submission Workflow
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Submission methods. For NIH, use the ASSIST method for submission unless it is not a choice. For all others, refer to the program announcement for specific instruction on the submission package and process. If using the adobe package, ensure that you have the correct software version that is downloadable from the grants.gov website.
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Regulatory submission process