Regulatory Correspondence definition

Regulatory Correspondence means any and all of the following: all applications, registrations, approvals, concurrences, and filings with, and other submissions and correspondence relating to any Acquired Asset, including to or from a United States or foreign patent office, any state counterpart, and any other Governmental Authority (in each case together with all supporting and background documentation).

Regulatory Correspondence means any and all of the following to the extent that they relate to any Product or the Exploitation of any Product and are in the possession of GENAERA as of the Effective Date: all applications, registrations, approvals, concurrences and filings with, and other submissions and correspondence relating to, any Products to or from the FDA, any state counterpart, any European notified body and any other foreign Governmental Authority with similar authority, and, with respect to FDA filings and submissions, identifying the type of the filing or submission (whether under an IND or NDA or otherwise), including all warning letters, all vigilance reports, all adverse event reports, all correspondence relating to clinical activities, all responses to FDA audits, all European notified body audits, all responses to European notified bodies, all CE technical or CE Marking files, all facilities registration documentation and all device listing documentation.

Regulatory Correspondence shall have the meaning set forth in Section 1.1(c).

Examples of Regulatory Correspondence in a sentence

• Disposition of Proposed Change Requiring Prior NRC ApprovalWill the proposed change determined to require prior NRC approval be either revised or rejected?Yes 🞏No 🞏If No, then initiate a License Amendment Request in accordance 10 CFR 50.90, AD-LS-ALL-0002, Regulatory Correspondence, and AD-LS-ALL-0015, License Amendment Request and Changes to SLC, TRM, and TS Bases, and include the tracking number:.Part VIII.

• In general, the film and the substrate have different coefficients of thermal expansion, and therefore as most of the films are deposited at elevated temperature Td , they will contract differentlywhen cooling down to the operating temperature T0 .

• IRB Access to Regulatory Correspondence Institutional policy should ensure that all individuals subject to IRB oversight, including investigators and their staff, are required to provide the relevant IRB (and the institution’s human subjects assurance signatory official) with copies of any correspondence, inspection reports, or audit findings to or from any federal, state, or local regulatory agency that bear upon the protection of human subjects.

• ANTICIPATED REMEDIAL INVESTIGATION WORK ACTIVITIES (JULY AND AUGUST 2021)Work Plans, Regulatory Correspondence and Meetings▪ In July, the PRPs will meet with the Agencies:o For a technical meeting to discuss RI reportingo To discuss Addendum 11 for 2021 groundwater monitoring▪ In August, the PRPs will meet with the Agencies for a monthly technical meeting to discuss RI reporting.

• Defined dates used on CBER correspondence and entered into CBER systems are described in regulatory job aid JA 820.02: Dating of CBER Regulatory Correspondence.

More Definitions of Regulatory Correspondence

Regulatory Correspondence means all applications, submissions, filings, reports or other documents, submitted or required to be submitted to any Governmental Authority, including the FDA, including amendments or supplements to any such documents and correspondence and other submissions related thereto (including minutes and official contact reports relating to any communications with any Governmental Authority), annual reports, safety reports, including Adverse Event reports, other periodic reports, and electronic establishment registration and drug listing files, as well as all correspondence received from such Governmental Authority and regulatory and clinical files and data pertaining to the foregoing in possession of Sellers or their respective Affiliates, whether in paper or electronic form.

Regulatory Correspondence means all applications, submissions, filings, reports or other documents, submitted or required to be submitted to any Governmental Authority, including the FDA, including amendments or supplements to any such documents and correspondence and other submissions related thereto (including minutes and official contact reports relating to any communications with any Governmental Authority), annual reports, safety reports, including Adverse Event reports, other periodic reports, and electronic establishment registration and drug listing files, as well as all correspondence received from such Governmental Authority and regulatory and clinical files and data pertaining to the foregoing in possession or control of Sellers or their respective Affiliates, whether in paper or electronic form.

Regulatory Correspondence has the meaning set forth in Section 4.17(g).

Regulatory Correspondence means any and all of the following: (i) all Regulatory Applications and all other applications, registrations, approvals, concurrences and filings with any Governmental Authority concerning or related to any Regulated Product or Device Regulation; and (ii) any other submissions, correspondence, or other communications relating to any Regulated Product or any Device Regulation, including any correspondence or communication to or from the FDA, any state counterpart, any Notified Body, or any other Governmental Authority (in each case together with all supporting and background documentation, and, with respect to FDA filings and submissions, identifying the type of the filing or submission (whether under a Regulatory Application procedure or otherwise)), including all warning letters, all vigilance reports, all MDRs, all correspondence relating to clinical activities, all responses to FDA audits, all CE technical or CE xxxx files, all facilities registration documentation and all device listing documentation.

Regulatory Correspondence means all correspondence including but not limited to letters with Health Regulatory Authorities.

Regulatory Correspondence means any and all of the following: all Regulatory Applications, and all other applications, registrations, approvals, concurrences and filings with any Governmental Authority concerning or related to any Regulated Product or Device Regulation; and any other submissions, correspondence, or other communications relating to any Regulated Product or any Device Regulation, including any correspondence or communication to or from the FDA, any state counterpart, any Notified Body, or any other Governmental Authority (in each case together with all supporting and background documentation, and, with respect to FDA filings and submissions, identifying the type of the filing or submission (whether under a Regulatory Application procedure or otherwise)), including all warning letters, all vigilance reports, all MDRs, all correspondence relating to clinical activities, all responses to FDA audits, all CE technical or CE mark files, all facilities registration documentation and all device xxxxing documentation.

Regulatory Correspondence shall have the meaning defined in Section 3.25(b).