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SEC Filings

10-Q
PROTEON THERAPEUTICS INC filed this Form 10-Q on 11/07/2017
Entire Document
 
 

Any product for which we obtain FDA approval will be subject to extensive ongoing regulatory requirements, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved.

 

Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical research, labeling, advertising and promotional activities for the product, will be subject to continual requirements of, and review by, the FDA and comparable regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, tracking, tracing, investigation, notification, and disposition obligations under the Drug Quality and Security Act, registration and listing requirements, current good manufacturing practices, or cGMPs, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. The FDA and comparable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval. If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates, they may withdraw approval, require labeling changes or establishment of a REMS or similar risk mitigation strategy, impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.

 

Even if regulatory approval of a product is granted, the approval will be subject to limitations on the indicated uses for which the product may be marketed and may be subject to other conditions of approval. We and our contract manufacturers will be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs and other regulatory requirements. In addition, approval may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. Discovery after approval of previously unknown problems with any such products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in actions such as:

 

  · restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
  · restrictions on a product’s manufacturing processes or facilities;
  · restrictions on the marketing of a product;
  · restrictions on product distribution;
  · requirements to conduct post-marketing clinical trials;
  · Untitled, Cyber, or Warning Letters from the FDA or similar correspondence from comparable regulatory authorities;
  · withdrawal of the products from the market;
  · refusal to approve pending applications or supplements to approved applications that we submit;
  · recall of products;
  · mandated modifications to labeling and promotional materials or requirements to provide corrective information to healthcare practitioners;
  · requirements to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
  · debarring us pursuant to the Federal Food, Drug, and Cosmetic Act, or FDCA, excluding us from participation in federal healthcare programs, requiring a corporate integrity agreement or debarring us from government contracts;
  · the imposition of costly new manufacturing requirements or use of alternative suppliers;
  · FDA or other regulatory bodies issuing safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about our products;
  · fines, restitution or disgorgement of profits or revenue;
  · suspension or withdrawal of regulatory approvals or refusal to approve future or pending applications or supplements;
  · refusal to permit the import or export of our products;
  · product seizure;
  · injunctions; and/or
  · imposition of civil or criminal penalties.

 

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