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The Food and Drug Administration Launches Program to Improve Safety of Drugs and Active Drug Ingredients Produced Outside the United States
Gastroenterology and Hepatology News continued
In healthy adults, the disease is usually self-limiting with good medical care, but it is more serious in the young, the old, and those with underlying medical conditions; the case-fatality ratio can be as high as 5%–10% in nurseries and nursing homes. Isolations of Salmonella causing gastroenteritis in humans have
increased in recent years in developed countries, primarily because modern methods of animal husbandry, food preparation, and distribution encourage the spread of the bacterium. For the latest developments in this investigation, including recalls and advice for consumers, visit FDA’s
Web page on the Salmonella Typhimurium Outbreak at http://www.fda. gov/oc/opacom/hottopics/salmonell atyph.html. The FDA has also created a searchable database for these products, which can be found at http://www. accessdata.fda.gov/scripts/peanutbut terrecall/index.cfm.
The Food and Drug Administration Launches Program to Improve Safety of Drugs and Active Drug Ingredients Produced Outside the United States
pliant. It also expedites the entry of products meeting the pilot’s criteria into the United States. “This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “This is one of several agency initiatives to enhance drug product safety.” Each applicant may designate up to 5 drugs for selection in the pilot program. To qualify, applicants need to meet the pilot program’s criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help to mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received. “With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate U.S. laws,” said Michael Chappell, acting Associate
Commissioner for Regulatory Affairs at FDA. “Consumers should know that only companies that maintain control over their products will be selected into this pilot program.” Companies wishing to participate in the 2-year pilot program must meet certain criteria, including:
The pilot program is planned to run for 2 years. To view the application for the program, see: http://www.fda.gov/ cder/fedreg/fda-3676.pdf.
and Digestive and Kidney Diseases (NIDDK) has identified genetic markers that are associated with risk for ulcerative colitis. The findings, published January 4, 2009, in the advance online edition of Nature Genetics, bring researchers closer to understanding the
biological pathways involved in the disease and may lead to the development of new treatments that specifically target such pathways. “Our identification of some of the genes that lead to ulcerative colitis are giving us a first look into the causes of
T
he US Food and Drug Administration (FDA) on January 14, 2009, announced the launch of a voluntary pilot program that would help to promote the safety of drugs and active drug ingredients produced outside the United States. The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants need to meet the pilot program’s criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The goal of the pilot project is to allow the agency to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the import of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be com-
Identification of Genetic Markers for Ulcerative Colitis Could Modify Treatment
T
he Inflammatory Bowel Disease (IBD) Genetics Consortium funded by the National Institute of Diabetes 1132
●
For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
●
The active pharmaceutical ingredients imported must be used only to make FDA-approved drugs;
●
Foreign drug manufacturers and US establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
●
Applicants must show that their drug products use a secure supply chain.
In healthy adults, the disease is usually self-limiting with good medical care, but it is more serious in the young, the old, and those with underlying medical conditions; the case-fatality ratio can be as high as 5%–10% in nurseries and nursing homes. Isolations of Salmonella causing gastroenteritis in humans have
increased in recent years in developed countries, primarily because modern methods of animal husbandry, food preparation, and distribution encourage the spread of the bacterium. For the latest developments in this investigation, including recalls and advice for consumers, visit FDA’s
Web page on the Salmonella Typhimurium Outbreak at http://www.fda. gov/oc/opacom/hottopics/salmonell atyph.html. The FDA has also created a searchable database for these products, which can be found at http://www. accessdata.fda.gov/scripts/peanutbut terrecall/index.cfm.
The Food and Drug Administration Launches Program to Improve Safety of Drugs and Active Drug Ingredients Produced Outside the United States
pliant. It also expedites the entry of products meeting the pilot’s criteria into the United States. “This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “This is one of several agency initiatives to enhance drug product safety.” Each applicant may designate up to 5 drugs for selection in the pilot program. To qualify, applicants need to meet the pilot program’s criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help to mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received. “With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate U.S. laws,” said Michael Chappell, acting Associate
Commissioner for Regulatory Affairs at FDA. “Consumers should know that only companies that maintain control over their products will be selected into this pilot program.” Companies wishing to participate in the 2-year pilot program must meet certain criteria, including:
The pilot program is planned to run for 2 years. To view the application for the program, see: http://www.fda.gov/ cder/fedreg/fda-3676.pdf.
and Digestive and Kidney Diseases (NIDDK) has identified genetic markers that are associated with risk for ulcerative colitis. The findings, published January 4, 2009, in the advance online edition of Nature Genetics, bring researchers closer to understanding the
biological pathways involved in the disease and may lead to the development of new treatments that specifically target such pathways. “Our identification of some of the genes that lead to ulcerative colitis are giving us a first look into the causes of
T
he US Food and Drug Administration (FDA) on January 14, 2009, announced the launch of a voluntary pilot program that would help to promote the safety of drugs and active drug ingredients produced outside the United States. The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants need to meet the pilot program’s criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The goal of the pilot project is to allow the agency to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the import of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be com-
Identification of Genetic Markers for Ulcerative Colitis Could Modify Treatment
T
he Inflammatory Bowel Disease (IBD) Genetics Consortium funded by the National Institute of Diabetes 1132
●
For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
●
The active pharmaceutical ingredients imported must be used only to make FDA-approved drugs;
●
Foreign drug manufacturers and US establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
●
Applicants must show that their drug products use a secure supply chain.