By : Laurie Barclay, MD
October 16, 2008 — To "improve transparency and communication," the US Food and Drug Administration (FDA) has created a new Web page as a single-access point for a wide variety of drug-safety information targeting healthcare professionals and consumers.
"By placing Web links to these up-to-date resources on a single page, we're helping consumers and healthcare professionals find drug-safety information faster and easier," Paul Seligman, MD, MPH, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research (CDER), said in a news release. "This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use."
Links are provided on the new page to detailed information regarding the following aspects of drug safety:
Drug labeling, including professional labeling, patient labeling, and patient package inserts;
Drugs for which a Risk Evaluation and Mitigation Strategy has been implemented to ensure that the benefits of use outweigh the risks;
A searchable database of postmarket studies that drug companies are required or have agreed to perform so that the FDA will gain evidence concerning a drug's safety profile, efficacy, and optimal use;
A searchable database of clinical trials (ClinicalTrials.gov), which offers information about the objective of each trial, inclusion criteria, study sites, and contact phone numbers;
Drug-specific safety information, including safety sheets with updated information about the drug, pertinent FDA news releases, fact sheets, and podcasts concerning drug safety;
Quarterly reports notifying clinicians and consumers about drugs that have been flagged by data review through the FDA's Adverse Event Reporting System and that are being examined for potential safety issues, based on Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
Regulations and guidance documents, including the Code of Federal Regulations, FDA regulations related directly or indirectly to safety, selected safety regulations, FDA guidance documents, and CDER guidances on drug safety;
Access to the Medline Plus literature database;
Information about FDA's Drug Safety Oversight Board
Instructions on how to report safety issues and other drug-related problems to the FDA through its MedWatch program;
The FDA's response to the 2006 report by the Institute of Medicine about the future of drug safety.
Consumer articles about the safe use of medications and disposal of unused medications; and
Consumer information about drug safety.
The Food and Drug Administration Amendments Act of 2007 mandated the creation of this type of Web page, which is part of the FDA's ongoing initiative to address the safe use of medications throughout their lifecycle.
October 16, 2008 — To "improve transparency and communication," the US Food and Drug Administration (FDA) has created a new Web page as a single-access point for a wide variety of drug-safety information targeting healthcare professionals and consumers.
"By placing Web links to these up-to-date resources on a single page, we're helping consumers and healthcare professionals find drug-safety information faster and easier," Paul Seligman, MD, MPH, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research (CDER), said in a news release. "This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use."
Links are provided on the new page to detailed information regarding the following aspects of drug safety:
Drug labeling, including professional labeling, patient labeling, and patient package inserts;
Drugs for which a Risk Evaluation and Mitigation Strategy has been implemented to ensure that the benefits of use outweigh the risks;
A searchable database of postmarket studies that drug companies are required or have agreed to perform so that the FDA will gain evidence concerning a drug's safety profile, efficacy, and optimal use;
A searchable database of clinical trials (ClinicalTrials.gov), which offers information about the objective of each trial, inclusion criteria, study sites, and contact phone numbers;
Drug-specific safety information, including safety sheets with updated information about the drug, pertinent FDA news releases, fact sheets, and podcasts concerning drug safety;
Quarterly reports notifying clinicians and consumers about drugs that have been flagged by data review through the FDA's Adverse Event Reporting System and that are being examined for potential safety issues, based on Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
Regulations and guidance documents, including the Code of Federal Regulations, FDA regulations related directly or indirectly to safety, selected safety regulations, FDA guidance documents, and CDER guidances on drug safety;
Access to the Medline Plus literature database;
Information about FDA's Drug Safety Oversight Board
Instructions on how to report safety issues and other drug-related problems to the FDA through its MedWatch program;
The FDA's response to the 2006 report by the Institute of Medicine about the future of drug safety.
Consumer articles about the safe use of medications and disposal of unused medications; and
Consumer information about drug safety.
The Food and Drug Administration Amendments Act of 2007 mandated the creation of this type of Web page, which is part of the FDA's ongoing initiative to address the safe use of medications throughout their lifecycle.
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