Regulatory Affairs

2005 ◽  
pp. 191-226
Keyword(s):  
Regulatory Affairs

scholarly journals Differences between the European Union and United States of America in Drug Regulatory Affairs Affect Global Patient Safety Standards and Public Health Awareness: The Case of Deferasirox and Other Iron Chelating Drugs

Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 36
Author(s):  
George J. Kontoghiorghes
Keyword(s):  
Patient Safety ◽  
Generic Drugs ◽  
Benefit Assessment ◽  
Regulatory Control ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Regulatory Policies ◽  
Regulatory Affairs ◽  
Risk Benefit Assessment ◽  
The Eu

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.

Regulatory Affairs

2021 ◽  
pp. 39-46
Author(s):  
P. Michael Dubinsky
Keyword(s):  
Regulatory Affairs

The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

1995 ◽  
Vol 29 (4) ◽  
pp. 1133-1143 ◽  
Author(s):  
Kathryn Huntley ◽  
Mary Jo Veverka ◽  
Minna Golden
Keyword(s):  
Regulatory Affairs ◽  
Medical Dictionary
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