- The FDA announces a new draft of their guidance on standards for accepting data from overseas studies in medical device clinical trials. With the increase in overseas trials, the FDA is attempting to clarify its existing policies on how overseas trials can be designed. The draft guidance relates to the FDA’s practice of accepting sound data from trials in other countries. In a footnote, the FDA states, “This guidance is also applicable to those medical devices reviewed as biological products under the PHS Act through submission of Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs).”The FDA announces a new draft of their guidance on standards for accepting data from overseas studies in medical device clinical trials.
- Practical tips were developed by HHS OIG, the Association of Healthcare Internal Auditors, the American Health Lawyers Association, and the Health Care Compliance Association to help hospital governing boards with their compliance plan oversight obligations.
- Baker Tilly's insurance industry specialists discuss if captive insurance companies could be a solution for your organization.
- Medicare announces clarifications to home health payments instructing physicians, non-physician practitioners, and home health care companies how to submit claims for home healthcare services provided to Medicare patients for episodes beginning on or after January 1, 2015.
- CMS proposes a rule that would change the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program EHR reporting period in 2015 to a 90-day period aligned with the calendar year.
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