On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more
6/8/2018
/ Clinical Trials ,
FDA Approval ,
Institutional Review Board (IRB) ,
Manufacturers ,
Medical Research ,
New Legislation ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Right to Try ,
Trump Administration ,
Written Consent
FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more
The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more
In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more
2/5/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Continuing Medical Education ,
Enforcement ,
Exclusions ,
Medicaid ,
Medical Devices ,
Medical Research ,
Medicare ,
Payment Records ,
Penalties ,
Pharmaceutical Industry ,
Physicians ,
Reporting Requirements ,
Sunshine Act ,
Vendors