Search This Blog

Tuesday, November 2, 2010

DCGI becoming more and more vigilent and making the laws stringent in Pharma

it is well known by every personnel in pharma sector the recent updates of implementation of Certification of all the pharma bodies acording to Schedule-M and certifications w.r.t WHO are not beiong provided for every industry but basing in the requirement only these are being audited which was a daily process earlier to the recent implementation from 01 Nov. 2010 as mandatory for Schedule L (For GLP)leaving behind the industry plea to extend the timeline as it is 2 years from its release and again it is now concentrating on the formulation of Good distribution practices which might also become a mandatory guideline in future.

Monday, November 1, 2010

Draft Guidance for Qualifying Drug-Development Tools by USFDA

The US FDA issued draft guidance on the Qualification Process for Drug Development Tools.As per the document drug-development tools (DDTs) include biomarkers and patient-reported outcome instruments, among other things. The draft guidance also offers a mechanism for formal review by CDER to qualify the DDT.
“Qualification” means “a conclusion that within the stated context of use, the results of assessment with a DDT can be relied upon to have a specific interpretation and application in drug development and regulatory decision-making.”
In the draft guidance, FDA proposes stages for the qualification process, including consultation and advice with CDER (e.g., letter of intent, briefing, meeting, investigation), and review for the qualification decision. The agency intends to make public its information regarding qualified DDTs.