Guidance for Industry Clause Samples

The "Guidance for Industry" clause serves to provide recommendations, instructions, or clarifications to businesses or organizations regarding compliance with regulatory requirements or best practices. Typically, this clause outlines the expectations of a regulatory body, such as the FDA, and may include details on procedures, documentation, or standards that companies should follow when developing, manufacturing, or marketing products. Its core practical function is to ensure that industry participants have clear, authoritative direction to help them meet legal and regulatory obligations, thereby reducing uncertainty and promoting consistent compliance.
Guidance for Industry. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at ▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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Guidance for Industry. Draft Guidance issued by the FDA in July 2019. To the knowledge of Seller, there are no facts or circumstances that could reasonably be expected to preclude or interfere with (a) the transfer of the Purchased Assets to Buyer or (b) Buyer’s ability to use the Purchased Assets to obtain Priority Review or any other benefit associated with the Purchased Assets following the Closing. Seller has provided to Buyer true and complete copies of the Approval Letter and any other material communications between Seller or any of its Affiliates and the FDA regarding the Priority Review Voucher.
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Guidance for Industry. As of the Effective Date, the Company has submitted to the FDA all the clinical, nonclinical and related Module 1 documents of a New Drug Application for an Included Product with a prospective indication in Alagille Syndrome. The FDA has not required that such New Drug Application include any clinical trial data from currently ongoing or not yet initiated studies in order to accept for review or approve such New Drug Application. Neither the Company nor its Affiliates has received any notice indicating that the New Drug Application’s rolling review must terminate or cannot continue.
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Guidance for Industry. Draft Guidance issued by the FDA in July 2019, that in either case (i) or (ii) has been enacted, adopted, approved or imposed between the Effective Date and the Closing Date and adversely impacts the manner in which Buyer may use, receive, hold or otherwise exploit the Priority Review Voucher.
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Guidance for Industry. Draft Guidance issued in July 2019. To the Knowledge of Seller, there are no facts or circumstances that could reasonably be expected to preclude or interfere with (a) the transfer of the Purchased Assets to Buyer, or (b) Buyer’s ability to use the Purchased Assets to obtain Priority Review. Seller has provided to Buyer true and complete copies of the NDA Approval Letter and any other material communications between Seller, Albireo Pharma or any of their respective Affiliates and the FDA regarding the Priority Review Voucher.
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Guidance for Industry. Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration. Rockville, MD : s.n., June 2006.
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Related to Guidance for Industry

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  • How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.

  • Employees; Labor Relations The Company and its Subsidiaries are, and have at all times within the past five years been, in compliance in all material respects with all Laws relating to the employment of labor, including any provision thereof relating to wages, hours, collective bargaining, labor relations, employment practices, prohibited discrimination, immigration status, worker classification (including the proper classification of working as independent contractors and consultants and exempt or non-exempt), equal opportunity, leave issues, unemployment insurance, workers’ compensation, affirmative action, plant closing, layoffs, and employee health, safety and welfare. Neither the Company nor any Subsidiary is the subject of any Actions or Proceedings or other legal controversies, including strikes, slowdowns, work stoppages, lockouts or other material labor dispute, that is pending or, to the Knowledge of Sellers, threatened, which involve any past or current employees or contractors of the Company or any of its Subsidiaries, and no such Actions or Proceedings or other legal controversies have occurred within the past five (5) years. Neither the Company nor any of its Subsidiaries is or has been party to (or required to be a party to) or bound by any collective bargaining, or contract with a union or other similar labor-related representative or organization, and, to the Knowledge of Sellers, there exists no current union organizational effort with respect to any employees of the Company or any of its Subsidiaries. To the knowledge of Sellers, no employees of the Company or any of its Subsidiaries are represented by a union or similar employee representative or organization. No officer of the Company has notified the Company that he or she intends to terminate his or her employment with the Company. To the Knowledge of Sellers, no past or current employee of or consultant to the Company or any of its Subsidiaries is currently in violation of any Restrictive Covenant owing (i) to the Company or any of its Subsidiaries or (ii) to any other Person that would reasonably be expected to adversely affect the right or ability of any such individual to work for or provide services to the Company or any of its Subsidiaries.