Navigation Links
FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals

New website will contain safety reports on recently approved drugs, biologics

SILVER SPRING, Md., June 15 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.


Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA's website along with a brief discussion of the steps FDA is taking to address any identified safety issues.

Some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The new summaries provide a comprehensive look at safety data early in the product's post-approval life cycle and are based on reports by manufacturers, providers, consumers and others to the FDA's Adverse Event Reporting System (AERS) and the Vaccine Adverse Event Reporting System maintained by the FDA and the Center for Disease Control and Prevention; periodic safety information submitted to FDA by manufacturers; information contained in the medical literature; and data from ongoing drug and biologic studies.

Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies. The summaries will also include a brief discussion of any steps FDA may be taking to address these safety issues.

Under Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA is required to prepare the safety summaries within 18 months after a product's approval or after it has been used by 10,000 patients, whichever comes later.

"Conducting systematic, comprehensive, safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious risks and complements the FDA's analysis of safety data during drug development and the agency's routine monitoring of safety information after product approval," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in the FDA's Center for Drug Evaluation and Research.

"These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions about an individual's health," said Robert Ball, M.D., M.P.H., Sc.M., director of the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research.

Initial summary reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, depression and other conditions. The summary reports will be located on an FDA Web page that was first established in 2008 to serve as a portal for drug safety information.

For more information

Postmarketing Drug Safety Evaluation

Medwatch: What is a Serious Adverse Event?

Office of Surveillance and Epidemiology (OSE)

Media Inquiries: Karen Riley, 301-796-4674,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. DATATRAK Premieres Safety System at DIA
2. Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010
3. FDA Consumer Health Information - FDAs MedWatch Safety Alerts: May 2010
4. Abbotts Investigational MitraClip(R) System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves
5. New Data Reinforces Safety Profile of Abbotts Market-Leading XIENCE V(R) Drug Eluting Stent
6. ExpertRECALL Awards First Scholarships for Product-Safety Education
7. JCR and Hill-Rom Name Nurse Safety Scholar-in-Residence
8. New Data Demonstrate Safety, Efficacy of Stereotaxis for Patients with AFIB, VT and Congenital Defects
9. Improving Safety While Advancing the Pharmacy Technician Profession
10. FDA CONSUMER HEALTH INFORMATION - FDAs MedWatch Safety Alerts: April 2010
11. New Data Reinforces the Proven Safety and Effectiveness of the BIRMINGHAM HIP Resurfacing System
Post Your Comments:
(Date:11/25/2015)... 2015  The American Academy of Pediatrics (AAP), ... the March of Dimes cheered today,s signature into ... Act of 2015 (S.799), which takes much-needed ... exposed to drugs, such as opioids, and to ... three organizations have worked together leading advocacy efforts ...
(Date:11/25/2015)... 2015 On Tuesday, November 24, 2015, ... against Wright Medical Technology, Inc. for product liability ... hip implant device, awarded $11 million in favor ... trial and three days of deliberations, the jury ... defectively designed and unreasonably dangerous, and that Wright ...
(Date:11/25/2015)... Israel , November 25, 2015 ... KTOV ) (TASE: KTOV), a biopharmaceutical company focused ... treatment of various clinical conditions, today announced the closing ... American Depository Shares ( ADSs ), each representing 20 ... up to 3,158,900 ADSs. The ADSs and warrants were ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ... Q-Suite, announces the incorporation of Asterisk 11 LTS (Long Term Support) into its ... 11 LTS brings Q-Suite 5.10 up-to-date with a version of Asterisk that will ...
(Date:11/26/2015)... ... ... Inevitably when people think Thanksgiving, they also think Holiday sales and start ... and Cyber Monday massage chair sales to receive the best pricing on ... find the best massage chair deals, they can see all of the coupons in ...
(Date:11/26/2015)... ... November 26, 2015 , ... Somu Sivaramakrishnan announced today that ... Somu now offers travelers, value and care based Travel Services, including exclusive pricing ... well as, cabin upgrades and special amenities such as, shore excursions, discounted fares, ...
(Date:11/26/2015)... NE (PRWEB) , ... November 26, 2015 , ... Jobs ... searched by healthcare professionals and offered by healthcare staffing agency Aureus Medical Group ... during the month of October 2015 among those searching for healthcare jobs through the ...
(Date:11/26/2015)... ... 2015 , ... WorldCare International, Inc., the first company to ... Benefits Conference. The Employee Benefits Conference was hosted by the International Foundation of ... 2015. The conference was held at the Hawaii Convention Center in Honolulu, Oahu, ...
Breaking Medicine News(10 mins):