Official FDA Correspondence definition

Official FDA Correspondence means (i) any written correspondence from FDA on official FDA letterhead concerning IND 115750 or FDA enforcement action and (ii) any FDA Form 483 notice of inspectional observations concerning the manufacture of the Company Products.
Sample 1

Related to Official FDA Correspondence

  • Correspondence between the Company, the Union, or any member of the Union arising out of this Agreement or incidental thereto, shall pass to and from the Company, the Union and member by verifiable means.

  • Official Gazette means the Official Gazette of the Government;

  • Official sample means a sample of feed taken by the director in accordance with section 7. (ee) "Percent" or "percentage" means the percentage by weight.

  • Official device means a stamping applicance, branding device, stencil, printed label, or any other mechani- cally or manually operated tool that is approved by the Administrator for the purpose of applying any official mark or other identification to any product or the packaging material thereof.A

  • Official compendium means the official United States Pharmacopoeia National Formulary, official

  • Official Sign means a sign required by or erected under any statute or by-law or other directive of any federal, provincial or municipal government or agency thereof or any board or commission and shall include a permanent sign erected on a public road allowance to inform the public of the location of Business Improvement Areas, public buildings, hospitals, public libraries, institutions, places of worship, parks, recreational or educational facilities;

  • Official Image means an electronic image of an Eligible Bill, either created in accordance with the provisions of this Agreement or that otherwise complies with the requirements to permit negotiation and clearing of that Eligible Bill in accordance with the by-laws, standards, or Rules of the Canadian Payments Association.

  • Official map means a map drawn by municipal authorities and recorded in

  • Official Seal means the original(s) of the VA seal showing the exact form, content, and colors thereof.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Informal communications means any communication method other than written emails to the Point of Contact Person identified for this RFP.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Team Official means any person involved with the management, preparation or participation of a team (whether paid or unpaid), including the coaches, managers, medical staff, other support staff or any other person acting for or on behalf of a Club;

  • statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;

  • Official traffic-control devices means all signs, signals, markings, and devices not inconsistent with this chapter placed or erected by authority of a public body or official having jurisdiction, for the purpose of regulating, warning, or guiding traffic.

  • Officials means the director(s) of the Company and other persons nominated by the Company;

  • Oral communication means any oral communication uttered by a person exhibiting an expectation that such communication is not subject to interception under circumstances justifying such expectation, but such term does not include any electronic communication;

  • Public or private safety agency means a unit of state or local government, a special purpose district, or a private firm, which provides or has the authority to provide firefighting, police, ambulance, emergency medical services or hazardous materials response.

  • Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • official computer system means a computer system maintained by or on behalf of the authority for the sending, receiving, processing or storing of any information.

  • Investigating Department means any Department, Division or Unit investigating into the conduct of the Agency and shall include the Vigilance Department, Central Bureau of Investigation, the State Police or any other department set up by the Central or State Government having powers to investigate.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • international application means an application filed under this Treaty;