Riding in Cars with Researchers - Don't Fear the FDA

FDA stands for food and drug administration that is the regulatory authority and performs inspections in pharmaceutical research industries as if there are any protocol deviations affecting data and safety of drugs and it gives approval for the medication before its arrival to the market.

FDA has collaborations with various other regulatory bodies around the world and performs inspecting responsibilities as follows:

  1. Data integrity.
  2. Subject safety.
  3. Protocol deviations.
  4. Proper consent of subject for the trials.
  5. Appropriate conduct of the trial.
  6. Delegation of authority log.
  7. Regulatory binding.

All the researchers performing any research have to go through the processes and inspections from FDA and they should not be afraid from these FDA inspections when they have done high-quality work with the best of their ability. Minimal mistakes are found in the research work during monitoring visits but these can be improved.

All the possible mistakes should be minimized during the research works by seeking perfection to attain high quality results. FDA performs inspections for the good reasons to improve the quality research and to eliminate errors and deviations influencing data and drugs.

 

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