Clinical Programmer Analyst
Company: Parexel
Website: www.parexel.com
Position: Principal Clinical Programmer Analyst
Skills: INFORM 4.5(Expert)
Location: Hyderabad.
Send CV at: deepti.saxena@mafoi.com
Ma foi Management Consultant Ltd
Tel:+91 40 66508031 (Direct)
FDA is known to have issues with resources and people, so things get delayed often with FDA. When a generic drug maker like Ranbaxy (yes, the new indo-japanese drug company) submits a generic drug application to FDA it is supposed to take 180 days for the review to come around. During this period the application passes through three FDA divisions (thanks to the beaureacracy) and gets reviewed.
In a recent review by Health and Human services the median duration of an application review was 217 days, and 96% of the applications were rejected. Thats a problem since the economy needs generics to stay on the track. FDA cites that the common reason for rejection is poorly made drug applications.
FDA has extensive details on how generic drug applications have to be submitted, how they are reviewed : http://www.fda.gov/cder/handbook/anda.htm and regulations surrounding the new drug applications http://www.fda.gov/cder/ogd/#Laws
one thing we always relate to a doctor is the cryptic handwriting on the prescription notes, and that is soon going to change.
ePrescription or use of electronic tools to write a prescription are starting to find a strong place in US health care policy. There is some talk on incentives to doctors who adopt ePrescription, such as the insurer WellPoint (or Anthem) providing cash incentives to ePrescribing practices.
However there have been two challenges : 1. Drug Enforcement Agency (DEA) prohibits some classes of pain and ADHD drug to be prescribed electronically, 2. It takes time for the clinician to move to the new realm. Time is a very rare commodity for a clinician as you know.
All the major software and tech players in the ePrescription domain have teamed up to start the National ePrescribing Patient Safety Initiative (NePSI initiative). Please take a look at their wonderful website http://www.nationalerx.com/
