Final answer:
A practitioner must submit a written request to receive free samples of a drug from a manufacturer. The FDA oversees the entire process from drug development to post-market surveillance, ensuring safety and efficacy are maintained.
Step-by-step explanation:
A manufacturer (or a representative of a manufacturer) can only distribute free samples of a drug to a practitioner if the practitioner submits a written request for the free samples. This is part of the regulatory measures to ensure the proper distribution and use of medications.
The process of a drug's journey from research to the market involves multiple steps regulated by the Food and Drug Administration (FDA). Initially, significant laboratory data from animal trials are required along with an Investigational New Drug (IND) application to the FDA's Center for Drug Evaluation and Research (CDER). Following the acceptance of the IND, clinical trials may commence. If issues arise during these trials, the FDA may place a clinical hold until they are addressed. After proving safety and efficacy, the developers can file a New Drug Application (NDA) that details the drug's production and administration particulars. Advertising of drugs also falls under strict FDA guidelines, ensuring that advertisements provide a fair balance of information regarding the benefits and risks.
Post-approval, drugs continue to be monitored through pharmacovigilance systems to assess long-term safety and impact on specific patient groups. Pharmaceutical companies are mandated to monitor their products even after they have been allowed on the market to ensure continuous safety evaluation.