The FDA’s Drug Approval Process- Part 3 of a 3-part series

by Christie Bell, CLP

Final Steps and FDA Assistance

This is the third and final article of a three-part series written to orient inventors of FDA regulations and requirements for consumables, drugs, and devices.

In Part 1 we introduced an overarching scope of the purpose and process of the FDA. In Part 2, we detailed the innovator’s path from idea introduction, to human trials and FDA award. In this last article we will cover the first few steps that need to be accomplished to certify a drug or device, and we’ll offer resources for assistance. For a quick glance at the steps in the FDA approval process, please view this info-graphic:

The Center for Drug Evaluation and Research (CDER) evaluates new drugs before they can be sold to consumers. The center’s evaluation not only prevents quackery, but also provides medication prescribers and consumers the information they need to use the innovations wisely. CDER ensures that drugs, both brand name and generic, are effective and that the product’s benefits outweigh their known risks.

A drug sponsor (inventing company) seeking to certify their product with the FDA must first test the innovation for toxicity on animal subjects. Often, multiple species are used to gather basic information on the safety and efficacy of the compound being investigated.

After a compound is developed and animal testing conducted, an Investigational New Drug (IND) application is submitted to the FDA and will provide information on the toxicity results from the animal trials. The IND application must detail the composition of the drug, manufacturing process, and include a plan for testing the drug on humans.

Although many organizations charge a fee for assistance in the FDA compliance process, the best place to start for no-cost assistance is with the FDA itself. Regarding medical devices, the FDA has a program called “Device Advice: Comprehensive Regulatory Assistance.” “Device Advice” is the FDA’s Center for Device and Radiological Health (CDRH) premier text-based resource that explains many aspects of medical device law, regulations, guidance documents, and policies encompassing the entire product life.

For assistance in certifying a drug, the FDA can be reached by phone at 1(888) INFO-FDA. The FDA hosts Small Business Assistance on its website, and each of the five FDA regional offices provides support programs for inventors and small companies. These offices provide technical assistance in the form of “exchange meetings”, conduct educational workshops, and develop informational materials for potential drug sponsors.

The regional office responsible for assisting Montana businesses is in Seattle, Washington. Miriam Burbach is the point of contact and can be reached via email at, or by phone at (425) 302-0400.

In the coming months, MTIP will be hosting a webinar on getting started with the FDA drug and device approval process. Look for announcements in future newsletters.

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