backThe final rule—Clinical Trials Registration and Results Information Submission—became effective on January 18, 2017. This rule clarifies and greatly expands the information that pharmaceutical and medical device companies must submit for public disclosure about certain clinical trials. This webinar will clarify the definition of “Applicable Clinical Trials” that must be registered, as well as changes in registration information that must be submitted and timelines. We will discuss the major new requirement for the submission of results and adverse events for clinical trials of drugs and medical devices that have not yet been authorized for marketing for any use. In addition, we will consider the broader implications of expanded public disclosure of clinical trial data, including the potential ramifications for SEC-related disclosures. To help ensure that companies are prepared to comply with the new rule and address its implications, we will address the following key changes and issues:
- Expansion of adverse event data that must be disclosed, including all-cause mortality;
- Expansion of results data that must be disclosed, including the full protocol and statistical plan;
- Requirements related to voluntary submission of clinical data from trials that would not otherwise be required to be registered;
- Disclosure of information regarding expanded access (“compassionate use”) of investigational drugs;
- Emphasis on enforcement, including the role of FDA in implementing enforcement;
- Additional requirements mandated by 21st Century Cures.
King & Spalding Presenters:
- Alec Koch
- Beverly H. Lorell
- Christina M. Markus
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Questions
If you have questions concerning this Roundtable Webinar, e-mail lifesciences-healthcare@kslaw.com.