What Is the FDA Approval Process for Pharmaceuticals?

FDA approval process

The FDA protects and promotes public health by regulating a wide variety of products, including pharmaceuticals. Receiving authorization from the FDA before releasing a product to the market is an ethical practice, and one which should be adhered to.

Oakwood Labs offers long-acting injectables and other sustained release microsphere technology, all in an aseptic, FDA-approved environment. Our manufacturing facility is equipped to conduct Phase I, II, or III clinical trial material, which can be of assistance for pharmaceutical companies seeking to go through the FDA approval process.

An Overview of the FDA Approval Timeline

To ensure that pharmaceuticals are both safe and effective, the FDA approval process is designed to favor products that abide by their requirements and processes alike.

Under a standard review, the FDA approval timeline will start approximately 10 months after an application is submitted. From here, the timeframe for approval of each product can differ.

Who Is Involved in the FDA Approval Process?

On the research side, a pharmaceutical company will oversee the discovery and development of the product, pre-clinical research, and clinical research of a new market product. They will need to completely fill out the New Drug Application before undergoing the FDA approval process.

The company will then submit any information collected from the laboratory in their NDA. Once submitted, physicians from the Center for Drug Evaluation and Research, chemists, pharmacologists, statisticians, and other scientists from the FDA will collectively work to determine if the drug is ready for approval.

Completing the “Action Package”

As mentioned above, the FDA only reviews completed New Drug Applications. If all data is present, the FDA approval timeline begins. First, the technical discipline teams address their respective sections and prepare for the supervisory review. Inspectors will then conduct inspections at locations where clinical studies took place. This ensures that findings were collected in an ethical manner without tampered evidence.

Data, evidence, and notes are organized by a project manager and complied into an “action package,” which becomes the basis for FDA review. A senior FDA official will then review all of the information and determine whether the drug is suited for its intended use.

How Does the Process Change if Approval Is Not Granted?

The FDA reserves the right to either delay or deny a product that has been submitted. Once this occurs, the pharmaceutical company who submitted will receive a letter that declares the news and offers an opportunity to meet with the FDA to discuss issues.

Delayed or denied applications may receive hearings, corrections for later approval, or even withdrawal of the application altogether. Common reasons for denial or delay include issues of safety, manufacturing, or effectiveness.

What Occurs After Approval?

It is normal for a pharmaceutical company to receive approval and still need to resolve issues or questions that were developed during the FDA approval timeline. Once they are able to produce the necessary studies and data, the New Drug Application is complete.

The FDA will then work with the company to research the prescribing information. The FDA approval process is often concluded with labeling, where the FDA works with the pharmaceutical company to define the best uses for the drug and discuss the terms on which the drug was approved.

Risk management for the drug is addressed and the company will seek best practices for monitoring health while the drug is utilized. These practices take time to ensure that the product is performing as promised. Products approved by the FDA are always subjected to post-market safety monitoring to confirm their impact on the population.

How Does This Impact the Public?

If the FDA deems a product ready for consumption by the public, it is designated as approved. Consumers can then identify whether products they research are FDA approved through two sites: Drugs@FDA and the “Orange Book.” Both of these destinations are regularly updated to keep customers aware of approved products and other relevant information.

Connect with Oakwood Labs as You Undergo the FDA Approval Process

FDA approval of a product gives users of the intended population confidence that the drug’s advantages outperform its known and potential dangers. Oakwood Labs provides the proper team and environment to help you every step of the way.

If you are looking for a team to support you through the FDA approval process or want to learn more, contact us today!

Mark Ilhan