FDA Compliance - Techlink
 

Prescription Drug Approval Overview

When a pharmaceutical company invents a new drug, that company is required to submit an NDA (New Drug Application) to the FDA. The FDA reviews the application thoroughly, looking for objective proof that the proposed drug is safe and effective. The FDA will not approve an NDA until it is satisfied that the new drug is SAFE and EFFECTIVE.

Those are the basic requirements of a potential new drug; It does not matter who invents it. If you want to market a drug in the USA, you need to prove that the drug is safe and effective. If FDA officials feel that a new drug is safe and effective, they will deem the new product “approvable”. At this point, most of the major hurdles for the new product have been overcome. Also at this point, labeling issues will be ironed out and loose ends need to be taken care of. However, there can be further obstacles. The FDA can determine that a drug is safe and effective, but they may insist that more clinical trials be conducted. For example, the FDA may want more data on the drug’s effects on heart rhythm when it is mixed with another drug, or maybe some of the test subjects developed a side effect. The FDA may want more data on this so-called “approvable” product before final approval is granted.

When a drug company gets an approvable status for a potential product, it is cause for celebration, although sometimes there is a considerable delay between approvable status and final approval because the FDA and the company involved can not agree on final labeling.

Until final labeling issues are resolved, the product is put on hold. If you are a pharmaceutical company whose drug approval status is pending, you want to make sure that you behave yourself. At this point, pharmaceutical executives need to be sure that final approval of a product is not delayed because the company is perceived as having an issue with the FDA.

The next step in the process is that the approvable drug gets an official Approval letter. Once the drug company gets this approval letter (not to be confused with an approvable letter), the drug company is officially permitted to market the drug. If the new drug is truly innovative, and has life-saving potential, the FDA will deem it “Fast Track,” and the approval process can take as little as 6 months. If the new drug is not innovative (like another angiotensin II blocker, or some other me-too drug), the approval process can drag on for years.

Steps in the Drug Approval process

Synthesis & Purification The FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for use by the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects.

Animal Testing (short-term) Generally, two or more species (one rodent, one non-rodent) are tested, because a drug may affect one species differently from another. Animal testing is used to measure effects.

Animal Testing (long-term) Long-term testing in animals ranges in duration from a few weeks to several years. Some animal testing continues after human tests begin.

Institutional Review Boards are used to ensure the rights and welfare of people participating in clinical studies, and to make sure that participants are fully informed and have given their written consent.

Phase 1 Clinical Studies: Phase 1 includes the initial introduction of an investigational new drug into humans. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled and scientifically valid studies.

Phase 2 Clinical Studies: Help determine the common short-term side effects and risks associated with the drug.

Phase 3 clinical studies: Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

Your Trusted Source For Compliance.