Navigation Links
US FDA and NIH Launch Web-Based Safety Reporting Portal to Increase Adverse Events Reporting of FDA-Regulated Products, According to FDAImports.com, LLC
Date:5/28/2010

On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched the Safety Reporting Portal (SRP) web site allowing increased accessibility to submit reports concerning FDA regulated products. SRP allows even the concerned citizen to submit a safety report related to foods, drugs, and veterinary products. “As access to this internet tool increases,” says Benjamin L. England, Food and Drug Law professional and founder of FDAImports.com, LLC, “the number of safety reports to FDA will certainly increase as well.”

(Vocus) May 28, 2010 -- On May 24, 2010, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) launched the Safety Reporting Portal (SRP) web site allowing increased accessibility to submit reports concerning FDA regulated products. SRP allows even the concerned citizen to submit a safety report related to foods, drugs, and veterinary products. “As access to this internet tool increases,” says Benjamin L. England, Food and Drug Law professional and founder of FDAImports.com, LLC, “the number of safety reports to FDA will certainly increase as well.” Because some safety reporting is mandatory for certain products by some private manufacturers and processors, ‘required organizations,’ use of the SRP will become the upgraded replacement for all safety reporting to FDA. For instance, the SRP now replaces FDA’s previous Reportable Food Register. One upgrade to the electronic and online reporting system permits consumers to submit reports concerning adverse events and products. Product Manufacturers, Processors, Packers, Warehouses, Researchers, and Health Care Professionals already had the ability (and sometimes the duty) to report safety problems to FDA.

Currently, in order to report an adverse event to FDA, even federal investigators, as well as required organizations, must submit duplicate reports to several federal agencies. Each of these reports requires use of different forms, vocabularies, reporting timeframes and criteria. The SRP standardizes all submitting requirements across commodities, industries and market participants. Previously, multiple agencies were receiving the same safety report in varying formats. This had the potential to cause confusion among government authorities concerning which department should investigate and potentially take enforcement action. “SRP shows that FDA and NIH are serious about taking action toward uniting and coordinating the diverse Federal requirements that are currently in place for the reporting and reviewing of adverse events,” says Benjamin England.

Similar to the old portal system SRP requires certain organizations to submit Mandatory reports relating to Reportable Foods, Animal Drug Safety, and Gene Transfer Research. SRP now enables anyone who has internet access, including consumers, the ability to report a safety concern voluntarily. SRP was created with advanced software that makes reporting a problem or concern simpler than ever before. “This is a very simple system to access,” says Benjamin England, “Simplicity leads to more reports, including those from consumers, which is likely also to lead to a higher number of lower quality reports that FDA must sift through.”

FDAImports.com, LLC is a consulting firm founded by Benjamin L. England who has 17 years of experience working inside the FDA. If you have concerns regarding the safety of your product contact FDAImports.com, LLC to speak with a Food and Drug Law specialist before an adverse events report is submitted targeting your product. FDAImports.com works side-by-side with Federal Regulations and can show you ‘the way through’ the US market while complying with safety guidelines.

###

Read the full story at http://www.prweb.com/releases/safety_reporting_portal/imports_FDA_NIH_SRP/prweb4064094.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Russell Organics Launches Certified Organic Rose Hip Oil Product
2. Lemons to Aid Launches Pediatric Kit
3. Italian Custom Bike Company Enters US Market and Chooses Premiere Arizona Marketing Firm for their Western Launch
4. Projects In Knowledge Launches Free iPhone App of Living Medical Textbook Neurology: Parkinson's Disease Edition
5. SaveUSJobs.org Launch “We Care Weekends” a Collaborative Solution to Employ Los Angeles, Inviting People to Make a Difference
6. GlassesUSA.com Launches Section for Prescription Sunglasses
7. George Carter of Carter's Plumbing & Rooter Announces the Launch of His New Website, CartersPlumbingRedondoBeach.com
8. Jusuru Tops New Company Launch Rankings
9. BuyDirectUSA.com Launches 'Operation Honor a Veteran'
10. Mobile Clinic Management EMR for Patient Health Information Launched by JAG Products and Canvas Partnership
11. WebPublished Launches Dynamic Rich Expressive Digital Publishing Platform for Digital Textbook or Magazine Publishers
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
US FDA and NIH Launch Web-Based Safety Reporting Portal to Increase Adverse Events Reporting of FDA-Regulated Products, According to FDAImports.com, LLC 
(Date:2/22/2017)... ... February 22, 2017 , ... The SeniorCare Investor will host ... —on Thursday, February 23, 2017, at 1:00 PM ET. A recording of the webinar ... the Interactive Webinar Series. , If you want to find out what really happened ...
(Date:2/22/2017)... ... , ... BrightStar Care Charleston , a home care and medical staffing ... (MUSC) Center on Aging’s Senior Expo on Thursday, March 23, 2017, at the ... resource in our community. We are thrilled to participate in this event because we ...
(Date:2/22/2017)... BAY AREA - NORTHERN CALIFORNIA (PRWEB) , ... ... ... aims to expand the pipeline and the number of African American/Black students ... encourages medical students and residents to pursue their careers as physicians in the ...
(Date:2/21/2017)... CA (PRWEB) , ... February 21, 2017 , ... Doctors ... , CA, directed by Dr. Kendell Mendonca , to its growing network of ... compensation injuries including injuries stemming from car accidents such as whiplash, back pain, neck ...
(Date:2/21/2017)... ... February 21, 2017 , ... American Veterinarian™, the premier multimedia ... launching its first bi-monthly issue of 2017 in February. The inaugural issue will ... One Health. , In making the announcement, American Veterinarian™ Publisher Chris Hennessy ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... DUBLIN , Feb 22, 2017 Research ... Devices Market Analysis & Trends - Industry Forecast to 2025" report ... The ... of around 5.2% over the next decade to reach approximately $2.1 billion ... estimates and forecasts for all the given segments on global as well ...
(Date:2/22/2017)... VALENCIA, Calif. , Feb. 22, 2017  Bioness, ... rehabilitation therapies, today announced the first series of successful ... at Radboud University Medical Center (Nijmegen, ... University ( Cork, Ireland ), and Kliniek ... With the successful launch continuing, Bioness plans to further ...
(Date:2/22/2017)... NetworkNewsWire Editorial Coverage: The cannabis industry is heating up. More ... legalized marijuana for medicinal or recreational use, and several countries, including ... Jamaica , Mexico , ... and the Netherlands , have also ... years. As a result, the cannabis industry has become ripe with ...
Breaking Medicine Technology: