Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Combination Products (OCP) published the final guidance “Principles of Premarket Pathways for Combination Products,”...
Source: jdsupra.com
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Top News In Cures Act Today - Breaking & Trending Today
More Work Needed to Restore Trust in the Public Health System, Says AMA President
Gerald Harmon, MD, calls for an end to the 'pandemic of mistrust'
Source: medpagetoday.com
2022 will be a 'transformative year' for health IT, says ONC head
National Coordinator for Health IT Micky Tripathi points to information blocking, API standardization and TEFCA as key factors in enhancing critical interoperability.
Source: healthcareitnews.com
FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products - Food, Drugs, Healthcare, Life Sciences
The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs.
Source: mondaq.com
Medical Records Ownership And The Information Blocking Rules - Food, Drugs, Healthcare, Life Sciences
Patients may think they own their medical records. While patients certainly have the right to access and, in many cases, control how their health information is used and disclosed, medical records ownership can be murky.
Source: mondaq.com