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Waxman-Hatch Act (1984 Drug Price Competition and Patent Term Restoration Act)

The 1984 Drug Price Act extended patent terms to account for the time it took a drug to receive FDA approval, and it reduced the barriers to entry for generic drug producers by allowing them to assert safety and efficacy based on information in the original NDA and on a proof that the original drug and generic drug are bioequivalent. The submission procedure for a generic drug is called an Abbreviated New Drug Application (ANDA).

Essential Documents and Trial Master File

  1. Define what is in-house site file and trial master file?
    Trial master file (TMF) is a file that contains all the essential documents relating to a clinical trial, before the trial commences, during trial conduct and after the completion of trial.
    The clinical trial related essential documents should be filed in the files for easy retrieval of data/information and audit/inspection. Based on the location and contents, it can be divided into 3 files:
    In-house study file: The In-house study file consists of essential documents, which are central in nature, received from sponsor/regulatory authorities relatedness investigational product/approval/process, original contracts with sponsor and third party (if exists) e.g. Regulatory approvals, GMP certificates, insurance, indemnification etc. This file is kept at CRO/sponsor office.
    Investigator site file (ISF): This file consists of essential documents related to that specific investigator site. This is kept at the investigator site.
    In-house site file: It consists of essential documents related to all the investigator sites. This is kept at the sponsor/CRO office. This file is essentially an in-house replica of the Investigator Site File maintained at the site.
  2. During the trial where signed informed consent forms should be located whether it is located at Investigator / Institution or copy should be in Sponsor's/CRO file?
    We have to follow ICH-GCP. The consent forms are a confidential transaction between the investigator and the subject. Hence, the signed consent forms cannot be taken out of the institution by the sponsor/CRO for their files.

 

 
 


Opinion Poll

Which organizations listed below would you say has the greatest responsibility in educating the public about clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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