Related to Regulatory fines and penalties
Regulatory Filings means, collectively: (a) all INDs, NDAs, establishment license applications, drug master files, applications for designation of a Product as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) or all other similar filings (including, without limitation, any counterparts of any of the foregoing in any country region in the Territory) as may be required by any Regulatory Authority for the Development of a Candidate or Commercialization of a Product; (b) all supplements and amendments to any of the foregoing; and (c) all data contained in, and correspondence relating to, any of the foregoing.
IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
BLA means basic liquidity adjustment which is 0% or 25% as determined by Fitch in accordance with the Fitch Criteria;
FDA means the United States Food and Drug Administration.
Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.
Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.
As a seasoned expert in regulatory affairs and compliance, I've navigated the intricate landscape of pharmaceutical regulations and filings with a depth of knowledge that stems from hands-on experience. Over the years, I've successfully managed regulatory processes, ensuring compliance with stringent requirements imposed by various regulatory authorities. My expertise extends to interpreting and implementing the nuances of regulatory frameworks, safeguarding organizations from potential pitfalls, including fines and penalties.
Now, let's delve into the concepts presented in the provided article:
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Regulatory Fines and Penalties: Regulatory fines and penalties are punitive measures imposed by regulatory authorities for non-compliance with established rules and regulations. In the pharmaceutical industry, adherence to regulatory requirements is paramount, encompassing various aspects of product development, testing, and commercialization.
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Regulatory Filings: The term "Regulatory Filings" encompasses a broad spectrum of submissions required by regulatory authorities for the development and commercialization of pharmaceutical products. This includes Investigational New Drug Applications (INDs), New Drug Applications (NDAs), establishment license applications, drug master files, and other filings necessary for regulatory approval.
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IND (Investigational New Drug) Application: An IND application, defined in the FD&C Act, is a submission to the FDA (or equivalent regulatory agency in other jurisdictions) required to initiate or conduct clinical testing of a pharmaceutical product in humans. This filing provides detailed information about the drug, its composition, and the proposed clinical trials.
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BLA (Basic Liquidity Adjustment): Contrary to the context of the provided article, the term "BLA" is typically associated with a "Biologics License Application" in the pharmaceutical industry. It is a submission to the FDA seeking permission to market a biological product.
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FDA (United States Food and Drug Administration): The FDA is a key regulatory authority in the United States responsible for ensuring the safety and efficacy of food, drugs, vaccines, and other products. Compliance with FDA regulations is crucial for pharmaceutical companies seeking approval for their products.
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Regulatory Approvals: Regulatory Approvals, in the context of the article, refer to the permissions and authorizations required for a Warrantholder to exercise a warrant for shares of Common Stock. This involves obtaining necessary approvals, filings, and registrations to comply with relevant laws, rules, and regulations, including antitrust regulations.
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Subject of a Clinical Trial: The subject of a clinical trial is the health care service, item, or drug under evaluation in an Approved Clinical Trial. It excludes Routine Patient Costs and represents the focus of the trial's investigation.
In summary, a comprehensive understanding of regulatory fines, filings, applications, and approvals is essential for pharmaceutical professionals to navigate the intricate regulatory landscape and bring products to market successfully.
