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Jury Verdict Research, a database of plaintiff and defense verdicts, says awards in medical liability cases increased 43 percent in 1999, from $700,000 to $1,000,000. However, more recent research from the U.S. Department of Justice has found that median medical malpractice awards in states range from $109,000 to $195,000.
The first list of approved drugs, with information on how they should be prepared, was the London Pharmacopoeia, published in 1618. The first edition of what is now known as the British Pharmacopoeia was published in 1864, and was one of the first attempts to harmonise pharmaceutical standards, through the merger of the London , Edinburgh and ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Medical guideline. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the ...
The numbers have jumped from 2018 when just four, or 7%, of the 59 new drugs were approved under those rules. The rules were created to be used in rare cases in which seriously ill patients had no ...
Good clinical practice. In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others ...