Navigation Links
Better Communication With FDA Could Speed Up Approval Of New Drugs

A new report commissioned by the Food and Drug Administration has found that newer medicines could hit the markets sooner if regulators met with the drug makers and apprised them of their concerns regarding that particular// medication before it went into the final phase of human testing.

The report by consulting firm Booz Allen Hamilton, on behalf of the FDA said that 53 percent of drug makers who met with the FDA before conducting trials had their applications approved out of a total of 77 applications received between 2002 to 2004.Compared to this only 29 percent of drug makers who did not meet up with the FDA had their medicines approved. "We have seen a pretty dramatic growth in the number of meetings we're having with sponsors in the past several years. Any additional workload for meetings is going to have to be supported by additional staffing," said Dr. John Jenkins, director of the FDA's Office of New Drugs. He added that the FDA would discuss this issue in the next meeting and would also take a note of the fees paid for such reviews. The report added that many drugs that failed to clear the first cycle were deficient in only a couple of areas and that had the FDA voiced these concerns, the companies would have been able to fix them. "Early and open communication with the sponsors will allow sponsors to address/resolve issues in a timely manner, potentially within the first review cycle," the report stressed. Dr Jenkins admitted that the communications segment of the FDA had room for improvement, but "some of the burden relies on the sponsors to make sure they understand what is being told." The report also noted that smaller companies had a tough time getting regulatory approval for their products, "Large, U.S.-based companies have the highest first-cycle approval rate, at approximately twice the rate of small biotechnology companies with no prior FDA approvals," it concluded.
'"/>




Page: 1

Related medicine news :

1. Better prostate cancer detection
2. Better Treatment for obesity
3. For a Better Memory
4. Baby Talk Better Than Adult Speech
5. Drug Combo Works Better for children with ADHD, Tics
6. Better skin with lasers
7. Better diabetes treatment promises Vanadium
8. Better Prostate Cancer Test
9. Better Drug for Heart Transplant
10. Better Diet Even Late in Life May Prolong It
11. Better Care Required for Breast Cancer Survivors
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:7/23/2017)... ... 23, 2017 , ... Better education to coaches and parents ... work today at the American Orthopaedic Society for Sports Medicine’ s ... to prospectively document the association between sports specialization and lower extremity injuries in ...
(Date:7/23/2017)... ... July 23, 2017 , ... “Squiggy’s Outdoor Adventure”: a turtle’s backyard ... the creation of published author, Paula Christian, a wife and mother to three amazing, ... family, who center their lives on God. She loves to tell stories to ...
(Date:7/21/2017)... ... , ... "As a doctor of lung medicine managing chest diseases for more ... said an inventor from Center Valley, Pa. "My idea is to improve the device ... the patent-pending PLEURAL SAFE-t-STAT CATHETER KIT to offer an efficient means of draining pleural ...
(Date:7/21/2017)... ... July 21, 2017 , ... The Karen Miller Agency, a ... in the greater Birmingham area, is joining the Chris Hammond Youth Foundation in ... the region. , The Chris Hammond Youth Foundation maintains athletic facilities in rural ...
(Date:7/21/2017)... ... July 21, 2017 , ... Bernard R. Bach, Jr., MD, orthopaedic surgeon at ... Orthopaedic Society of Sports Medicine (AOSSM) , received the 2017 Robert E. Leach Sports ... Toronto, Canada. This prestigious award is given annually to honor those who have made ...
Breaking Medicine News(10 mins):
(Date:7/14/2017)... 13, 2017 It should come as no surprise ... is in the midst of a crippling opioid epidemic. According ... the number of overdose deaths from opiate-based medications has quadrupled, ... a million dead from 2001 to 2015". During this time, ... has similarly quadrupled, drawing a compelling link between prescription and ...
(Date:7/13/2017)... 2017 RK Logistics Group, Inc. was awarded ... its Fremont, CA headquarters facility where ... and San Jose for hi-tech, pharmaceutical ... , with its Fremont Innovation District, is excited to ... powerful resource to the hundreds of biotech, pharma and biomed ...
(Date:7/12/2017)... -- CarpalAID is a revolutionary new product that relieves painful carpal ... tunnel syndrome affects more than 8 million people a year. Women ... The common methods of treating CTS are painful surgery, the use ... gloves. ... CarpalAID is a clear patch worn on the palm of the ...
Breaking Medicine Technology: