Questions in Our Mind
Questions in Our Mind
mind
By: Pundalik
Pai
Questions are very
important
A person asking a question is at that moment a self-motivated learner i.e. a researcher. This is the behavior we should try to nurture.
E.g. Evolution
My Question
Is there a difference between CRO,
SMO and RMO?
CRO - Contract Research Organization
A Contract Research Organization (CRO) is a company
contracted by a pharmaceutical or biotechnological
manufacturer to manage clinical trials. CROs perform
services such as, data management, statistical analysis,
protocol design, and final report development. e.g. Quintiles,
paraxel etc.
A CRO is an independent contractor with the sponsor.
One or more of the obligations of a sponsor, e.g. design of a
protocol, selection or monitoring of investigations, evaluation
of reports, and preparation of materials to be submitted to the
FDA etc. are handled by CRO.
SMO - Site Management Organization
A Site Management Organization (SMO) performs and manages
research for individual Investigative Sites. SMOs'
responsibilities include patient recruitment and protocol
management. e.g. many hospitals, Klintelligen, Comargo etc.
A SMO is an independent contractor with the CRO /
clinical investigator and their one or more of the regulatory
obligations e.g., preparation and maintenance of case histories,
ensuring compliance with IRB review and informed consent
requirements, AE reporting etc. are handled by SMO.
RMO - Research Management Organization
A Research Management Organization (RMO) functions as a
combination of a CRO and SMO to manage research from the
conception and development of a project to the implementation
and completion at Investigative Sites. e.g. Advinus
My Question
Hatch-Waxman Act
History-
Drug approval process in 1962
Challenges for generic mfg’s and innovators
Need for an amendment in federal Food, Drugs and Cosmetics act.
In1984 Hatch-Waxman act as an amendment
Also called “Drug Price Competition and Patent Term Restoration
act1984”
OBJECTIVES OF HATCH-WAXMAN ACT
1. Reducing the cost associated with the approval of a generic drug.
2. Allowing Early-Experimental-Use.
3. Compensating the branded drugs manufacturers for the time lost from
the patent term because of the regulatory approval formality.
4. Motivating the generic drug manufacturers: Exclusivity.
My Question
Submission options (NDA)
Which act covers the submission of NDA?
Three types of submission are available under Section
505 of chapter V of the Federal Food, Drug and Cosmetic
Act:
1. 505(b)(1)
2. 505(b)(2)
3. 505(j)
Section 505(b)