Navigation Links
FDA Official States Need for Greater Data from Public Stakeholders and Industry to Inform the Guidance Process for use of Internet and Social Media in the Promotion of FDA-regulated Medical Products
Date:2/9/2010

is date.  This news is particularly important to companies that are in the process of planning or currently conducting research but might not have it completed or analyzed in time.  In such cases, she recommends that companies provide the FDA with some kind of advanced notice that they are planning on submitting late.  Submitting an outline or abstract of the research could also prove useful.  

"I believe the FDA is truly committed to engaging the industry and moving this process forward. By issuing this request, they are creating better clarity on how the industry can supply them with the right data to support the development of guidance that will enable them to effectively, appropriately, and compliantly communicate using these tools," said Gratton, who was also one of the presenters at the public hearings last November.

In her interview with Mr. Gratton, Dr. Kang provided clarification and direction to the industry, including the Agency's perspective on technology and social media, thoughts on the public hearing itself, what to expect from the ongoing guidance process, more details about the extended period for data submission, and her recommendations for what companies should be doing in the meantime.

Other highlights from the interview include Dr. Kang's comments on:

  • How the guidance process works
  • Why starting data gathering today is not useless
  • What the FDA can do to help
  • How best to stay apprised of new developments
  • When the FDA will make its next public appearance

"I think it's our responsibility as an industry to provide the FDA/DDMAC with as much supporting data as possible, so at the end of this journey we will have contributed to the development of guidelines that are specific enough to be actionable, broad enough to endure, and permissive enough to enable safe, effective, and responsible us
'/>"/>

SOURCE inVentiv Health
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Toxic Chemical bisphenol A Still Not Banned By FDA; Schumer, Gillibrand Call for Ban; Govt Official Warns Public
2. Health Robotics Announces Official i.v.STATION(TM) Inauguration at Gregorio Maranon University Hospital
3. BASF Officially Launches the Collaborative Advanced Research Initiative at Harvard University
4. Top Washington Health Officials to Honor Framingham Heart Study Participants
5. State, Federal Officials Remind Health Care Workers, Other at-Risk Individuals to Get Annual Flu Shot
6. An Open Letter to Parents, Students, School Administrators, & Health Care Officials from Soapopular(R)
7. Pulse Systems Announces New Sales Representation in the Western United States
8. United States Seizes Unapproved Ozone Generators
9. SUMAVEL(TM) DosePro(TM) Available in the United States to Treat Acute Migraine and Cluster Headaches
10. Novel Radiation Therapy to Treat Lung Cancer Used for the First Time in United States, at New York Hospital Queens
11. Connectyx Announces Distribution Partnership with United States Medical Supply
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... 23, 2015 More than a third of reproductive-aged women ... with private insurance, filled a prescription for an opioid pain ... this week,s Morbidity and Mortality Weekly Report (MMWR). ... treat moderate to severe pain.  They are also found in ...
(Date:1/23/2015)... , Jan. 23, 2015 /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ... directors of Advaxis, Inc. ("Advaxis" or the "Company") (NASDAQ: ... breached its fiduciary duties to shareholders. On ... investing website reporting that Advaxis had misrepresented the clinical ...
(Date:1/23/2015)... 23, 2015  HyGreen, Inc., a leader in hand hygiene ... RCA Medical, a subsidiary of Ascendis Health Limited, in ... Each year, hundreds of millions of patients around the ... are transmitted from patient to patient via the unwashed ...
Breaking Medicine Technology:Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2
... PARSIPPANY, N.J. , July 6 There are more than 374,000 smokers ... die from a smoking-related illness.(1) As of July 1 , they now have ... took effect in all restaurants, bars and workplaces as a result of the Kansas ... Research shows that policy ...
... that a new market research report is available in its catalogue: , ... Opportunities in Non-Surgical Bio-Implants: Marketed injectable ... , , ... , Injectable bio-implants ...
Cached Medicine Technology:Kansas Statewide Smoking Ban May Prompt Smokers to Quit 2Kansas Statewide Smoking Ban May Prompt Smokers to Quit 3Kansas Statewide Smoking Ban May Prompt Smokers to Quit 4Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 2Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 3Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 4Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 5Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 6Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 7Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 8Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 9Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 10Reportlinker Adds Opportunities in Non-Surgical Bio-Implants: Marketed injectable biomaterials, applications, and leading players 11
(Date:1/22/2015)... Carinsurancesavings.biz has released a new blog post ... insurance . , Purchasing an accidental death and dismemberment ... This type of rider provides benefits if the insured dies ... a lesser form of life insurance. , AD&D is ...
(Date:1/22/2015)... Jolla, Calif. (PRWEB) January 22, 2015 ... Assemblymembers Susan Bonilla (D-Concord) and Kristin Olsen (R-Modesto) ... for their leadership in advancing biotechnology, biomedical science, ... Bonilla and Olsen each received the “2014 Life ...
(Date:1/22/2015)... Four years since the release of their debut recording Love ... of Avasa & Matthew Love – the duo are pleased to ... through White Swan Records on February 24, 2015. , THE ROAD ... available to all of us to walk out of the mire ...
(Date:1/22/2015)... 2015 As interest in the value of ... momentum worldwide, Rev. Eric J. Hall , president and ... (HCCN), will be the keynote speaker on January 27 at ... health system. , The conference, “Hope and Resilience: Innovative and ...
(Date:1/22/2015)... a new blog post explaining the importance of keeping a first ... an auto insurance policy . , Clients who driver safer ... vehicle insurance policies. The safety a vehicle offers from its driver ... this, drivers should always carry a first aid kit in their ...
Breaking Medicine News(10 mins):Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2
... will die from prostate cancer this year. However, a ... combination of androgen suppression therapy (hormone therapy) with radiation ... of androgen, a male sex hormone. Researchers say that ... been shown to improve survival rates for prostate cancer ...
... and one of the oldest and most common types ... down and the bones rub against each other causing ... study shows an effective treatment for osteoarthritis is the ... was found to reduces gastric complications that often occur ...
... can reduce complications after a blood clot in the ... ,Some of the common complications with deep vein ... swelling, skin discoloration, numbness, chronic pain, hardening of the ... elastic stockings could help patients with blood clots, so ...
... public places can improve the overall likelihood someone will ... AEDs -- devices capable of shocking the heart back ... 1,000 shopping malls, apartment complexes, and other public places ... volunteers in these communities were then trained in either ...
... affects millions of people worldwide . It is the most ... Alzheimer’s disease are still unknown and there is no cure. ... the key to treating Alzheimer’s disease. A team of researchers ... 37. Some were given sage oil capsules, and some were ...
... patients who receive treatment have a greater risk of developing ... are not taking the necessary steps to prevent the clots ... determine if the doctors were aware of the risk of ... physicians. About 40 percent of the doctors who were surveyed ...
Cached Medicine News: