#fda compliant

[cnnnext]

FDA Has Ignored Tylenol Dangers For Over 40 Years

PROVIDED BY HTTP://CNNNEXT.COM Published on Oct 7, 2015 The dangers of prescription drugs are mostly well-known, but most people believe that their over the

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[cnnnext]

Diabetes Drug Invokana Linked to Ketoacidosis and Potential Kidney and Heart Failure

PROVIDED BY HTTP://CNNNEXT.COM Published on Aug 17, 2015 A blockbuster diabetes drug called Invokana has pulled in hundreds of millions of dollars for Big Pha

[compliancepanel]

FDA Regulation of Molecular Diagnostics 

There is a lot of confusion regarding the process for obtaining approval for commercial use of molecular diagnostics by FDA and reimbursement by the payers. The development steps, testing requirements prior to approval, role of CMS and FDA in certifying the tests and testing location, and scientific basis for approval vary from test to test. There is very little guidance from the FDA stating its expectations from a given test leading to the regulatory pathways being customized on a case-by-case basis. This webinar will answers the above questions providing practical tips to comply with FDA’s requirements.

This webinar is intended for general instructions to all molecular diagnostic providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA regulate such tests. Register here