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The Sunshine Act requires manufacturers of drugs, medical devices, biological and medical supplies covered by the three federal health care programs Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) to collect and track all financial relationships with physicians and teaching hospitals and to report these data to the Centers for Medicare and Medicaid Services (CMS).
50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials; 58 Good laboratory practices (GLP) for nonclinical studies; The 100 series are regulations pertaining to food: 101, especially 101.9 — Nutrition facts label related
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Florida Department of Financial Services (FLDFS) is a state agency of Florida.Its headquarters are in Tallahassee. [1] In 2002 the Florida Legislature merged the Department of Insurance, Treasury and State Fire Marshal and the Department of Banking and Finance into one department, the Florida Department of Financial Services.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
Good morning. The CFO’s office plays a vital role in compliance with the U.S. Securities and Exchange Commission’s (SEC) mandate to standardize climate-risk disclosures. Under the rules ...
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]