Discuss how regulatory agencies such as the FDA work with pharmaceutical companies to ensure medications are...

Discuss how regulatory agencies such as the FDA work with pharmaceutical companies to ensure medications are both safe and effective for the public

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Expert Solution

Pharmaceutical companies need FDA approval for the marketization or selling of the drugs in US. The FDA is the agency which regulates the quality and safety prospects of the pharmaceutical medications worldwide. US Food and drug administration works as statuary body ensuring the quality and safety of the medicines concerning the health of the society.

The pharmaceutical company works for the drug discovery and development. Then go through preclinical and Clinical trials under the USFDA guidelines. All phases of clinical trials like phase 1, phase 2 , phase 3 are essential for approval. Phase 4 clinical trial works as post marketing surveillance.

Then pharmaceutical companies need to submit the safety dossier to FDA for approval.

Only after getting approval they can launch the medicines in the market.

Thus FDA work with pharmaceutical companies to ensure medications are both safe and effective for the public.

Nightingale answered 1 year ago

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