Food and Drug Administration (FDA) Sample Clauses

Food and Drug Administration (FDA). We may use or disclose health information for purposes of notifying the FDA of adverse events with respect to food, supplements, product, and product defects, or post marketing surveillance information to enable product recalls, repairs, or replacements.
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Food and Drug Administration (FDA). The vendor will not have any outstanding actions from the FDA or other regulatory agencies or unresolved FDA warning letters on the manufacturing processes or quality control issues involving the products covered by this contract within the last 3 (three) years. VA will require proof from the vendors that the FDA issues have been resolved. A letter to the vendor from the regulatory agency will meet this requirement. Items involved in a recall cannot be added into this contract via modification until the recall is resolved.
Sample 1
Food and Drug Administration (FDA) will: Provide expertise in regulatory review of in vitro diagnostics (IVDs) and Emergency Use Authorization (EUA) authorities. Provide clinical and technical diagnostics expertise to facilitate discussions about planning and implementing surge capacity for diagnostic testing using FDA cleared, approved or EUA IVD assays that are approved/cleared/authorized for use in laboratories within the US healthcare system during emergencies. National Independent Laboratory Association (XXXX) will: Serve as a communications hub, facilitating linkages between its laboratory members and the MOU Parties. Identify, help develop, and disseminate guidance among its membership on biosafety and training necessities, utilizing experts within its membership. Participate in and help develop training for future public health emergencies, calling upon experts in its membership who have served in a variety of roles within clinical laboratories, public health laboratories, and academic health settings. Assist in identifying and engaging private sector laboratories to provide testing capacity for public health emergencies or an emerging pathogen outbreak with pandemic potential. COLA Inc. will: • Assist in engaging COLA-accredited laboratories to provide testing capacity for public health emergencies or an emerging pathogen outbreak with pandemic potential‌ • Provide clinical laboratories and training, education and preparedness activities • Provide education to address scientific, biosafety, regulatory, procurement and other needs of laboratories performing tests of public health significance. • Share information and engage XXXX’s member organizations American Medical Association (AMA), American Academy of Family Physicians (AAFP) and the American College of Physicians (ACP) when the MOU parties identify a need for physician support Administration for Strategic Preparedness and Response (ASPR) will: • Provide expertise and insights into ongoing and potential logistical and supply chain issues. As well as identify, help develop, and disseminate ongoing ASPR/IBMSC actions and potential resolutions. • Assist in identifying and engaging private sector manufacturers across the entire testing ecosystem of suppliers (raw materials and finished goods) to ensure sufficient testing capacity. • Provide expertise and insights into potential gaps/concerns, as it relates to forecasted testing supply and testing demand. • Rapidly coordinate and disseminate urgent ASPR/IBMSC actions, including, but...
Sample 1
Food and Drug Administration (FDA). XXXX X. XXXXXXX, PH.D., ABPP, LLC may disclose to the FDA, or persons under the jurisdiction of the FDA, PHI relative to adverse events with respect to drugs, foods, supplements, products and product defects, or post marketing surveillance information to enable product recalls, repairs, or replacement.
Sample 1
Food and Drug Administration (FDA). PADDOCK may disclose to the FDA, or persons under the jurisdiction of the FDA, PHI relative to adverse events with respect to drugs, foods, supplements, products and product defects, or post marketing surveillance information to enable product recalls, repairs, or replacement.
Sample 1
Food and Drug Administration (FDA) will: Provide expertise in regulatory review of in vitro diagnostics (IVDs) and Emergency Use Authorization (EUA) authorities. Provide clinical and technical diagnostics expertise to facilitate discussions about planning and implementing surge capacity for diagnostic testing using FDA cleared, approved or EUA IVD assays that are approved/cleared/authorized for use in laboratories within the US healthcare system during emergencies. The National Independent Laboratory Association (XXXX) will: Serve as a communications hub, facilitating linkages between its laboratory members and the MOU Parties. Identify, help develop, and disseminate guidance among its membership on biosafety and training necessities, utilizing experts within its membership. Participate in and help develop training for future public health emergencies, calling upon experts in its membership who have served in a variety of roles within clinical laboratories, public health laboratories, and academic health settings. Assist in identifying and engaging private sector laboratories to provide testing capacity for public health emergencies or an emerging pathogen outbreak with pandemic potential.
Sample 1

Related to Food and Drug Administration (FDA)

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Alcohol and Drugs Service Provider agrees that the presence of alcohol and drugs are prohibited on the Work Site and while performing their Services. If the Service Provider or any of their agents, employees, or subcontractors are determined to be present or with alcohol or drugs in their possession, this Agreement shall terminate immediately.

  • Medicines To be filled in if your child requires medication as part of an individual health plan, for example for an on-going condition such as asthma or eczema etc and is for the use of that child only. For staff: Individual health plan sighted and a copy taken: Tick One: Yes No Name of medicine: Method and dose of medicine: When does the medicine need to be taken: (State time or specific symptoms) Parent/Guardian Signature: Date: / /  Enrolment Details: Date of Enrolment: / / Date of Entry: / / Date of Exit: / / Please Note: 20 Hours ECE is for up to six hours per day, up to 20 hours per week and there must be no compulsory fees when a child is receiving 20 Hours ECE funding. Days Enrolled: Monday Tuesday Wednesday Thursday Friday Times Enrolled: Total hours: 20 Hours ECE at this service Total hours: 20 Hours ECE at another service Total hours: Parent/Guardian Signature: Date: / /

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Food and Drink (1) An employer must ensure that each child is provided with appropriate and sufficient nutritious food, having regard to the age, taste, culture and dietary restrictions of the child. (2) The food should be varied and should be served to children at reasonable hours. (3) An employer must ensure that water, fruit juice or other such drinks are readily available at all times to each child.

  • Prescription Drug Plan Retail and mail order prescription drug copays for bargaining unit employees shall be as follows:

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

  • Health Promotion and Health Education Both parties to this Agreement recognize the value and importance of health promotion and health education programs. Such programs can assist employees and their dependents to maintain and enhance their health, and to make appropriate use of the health care system. To work toward these goals:

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