Even if we, or any future collaborators, obtain marketing approvals for our product candidates, the terms
of approvals and ongoing regulation of our products may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.
Once marketing approval has been granted, an approved product and its manufacturer and marketer are subject to ongoing review and extensive
regulation. We, and any future collaborators, must therefore comply with requirements concerning advertising and promotion for any of our product candidates for which we or they obtain marketing approval. Promotional communications with respect to
prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the products approved labeling. Thus, we, and any future collaborators will not be able to promote any products we
develop for indications or uses for which they are not approved.
In addition, manufacturers of approved products and those
manufacturers facilities are required to comply with extensive FDA and International Conference on Harmonization, or ICH, requirements, including ensuring that quality control, quality assurance and manufacturing procedures conform to cGMPs,
which include requirements relating to quality control, quality assurance and the corresponding maintenance of records and documentation and reporting requirements. We, our contract manufacturers, any future collaborators and their contract
manufacturers could be subject to periodic unannounced inspections by the FDA, EMA, and/or any other regulatory authority to monitor and ensure compliance with cGMPs.
Accordingly, assuming we, or any future collaborators, receive marketing approval for one or more of our product candidates, we, and any
future collaborators, and our and their contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality assurance and control.
If we, and any future collaborators, are not able to comply with post-approval regulatory requirements and/or commitments, we, and any future
collaborators, could have the marketing approvals for our products withdrawn by regulatory authorities and our, or any future collaborators, ability to market any products could be limited, which could adversely affect our ability to achieve
or sustain profitability. Further, the cost of compliance with post-approval regulations may have a negative effect on our operating results and financial condition.
In order to market our medicines in the European Union and many other jurisdictions, we or any future collaborators must obtain separate
marketing approvals and comply with numerous and varying regulatory requirements. These regulatory requirements will vary among countries and approval by the FDA of our labeling and promotional activities does not ensure approval by regulatory
authorities in other countries or jurisdictions. Accordingly, the terms of approvals and ongoing regulation of our products may limit how we market our products in particular jurisdictions and that could materially impair our ability to generate
revenue.
Any product candidate for which we or any future collaborators obtain marketing approval could be subject to restrictions or withdrawal from
the market and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
Any product candidate for which we or any future collaborators obtain marketing approval, along with the manufacturing processes,
post-approval clinical safety and/or efficacy data, quality, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA, EMA, and other regulatory authorities. These
requirements include submissions of safety, efficacy, and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to quality control and manufacturing, quality assurance and corresponding
maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated
uses for which the product may be marketed or to the conditions of approval or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine, including the requirement to implement a risk
evaluation and mitigation strategy.
The FDA and other agencies in the U.S., including the Department of Justice, or the DOJ, closely
regulate and monitor the post-approval marketing and promotion of products to ensure that they are marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and DOJ impose
stringent restrictions on manufacturers communications regarding
off-label
use and if we do not market our products for their approved indications, we may be subject to enforcement action for
off-label
marketing. Violations of the FDCA and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations and enforcement actions
alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws. Similar laws and requirements are present and applicable in the European Union, as well as other geographies and countries.
In addition, later discovery of previously unknown or rare adverse safety events or other problems with our products, manufacturers or
manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:
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restrictions on such products, manufacturers or manufacturing processes;
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restrictions on the labeling or marketing of a product;
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