Drug Development and Approval Measures

Often an undiscussed topic, the development and approval process of certain medical supplies and drugs may appear mysterious to patients, caregivers, or physicians. The Food and Drug Administration (FDA) is responsible for the screening and approval of new drugs before they come into the market to ensure that all medicines meet a certain established standard for patient safety and drug efficacy.

Rx Care Pharmacy, a medical equipment pharmacy in Florida, would like to briefly explain the measures the FDA takes.

First, an interested drug company presents a new drug to the FDA through a New Drug Application (NDA) submission before it circulates in a pharmacy in Orlando, Florida, for instance. This submission should include laboratory documentation showing safety ad effectiveness in animal studies done by the company as well as human clinical trials. These trials (also called clinical studies) takes place in steps with increasing participants as the tests progress from Phase 1 through Phase 4. This may take several months or years to complete.

In order for companies that offer affordable medications in Florida to ship unapproved drugs to clinical sites for testing, they must attain an exemption from the FDA to ship the experimental medicines; in other words, an IND (investigational new drug.)

Once fulfilled, the FDA will go over the NDA and all other data and if approved, will decide how the drug will be labeled, inspect the manufacturing facility and then approve the drug.