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What is the FDA?

The FDA (Food and Drug Administration) is an agency that works to enforce optimal public health by putting in place measures to safeguard the security, efficacy, and safety of drugs for both veterinary and human applications.

Food and Drug Administration
Image source: wikipedia

They also ensure the same standards are met when it comes to medical devices, radioactive products, and other biological products. The FDA’s enforcement guarantees consumers in America that they will get to enjoy the most innovative, advanced, and safe pharmaceutical system the world has to offer.

Quite notably, the FDA is recognized for their evaluation of new drugs before they can hit the market. This evaluation ensures that drugs being put forward work as they are supposed and pose minimal risks in comparison to their benefits. These evaluations are carried out at the Center for Drug Evaluation and Research (CDER), which is tied to the FDA’s mandates. Manufacturer’s who ask, “What is the FDA process like?” will find their answer in this article.

What is the FDA process like?

The FDA process can be culminated into five recognized steps. These are:

  • Conception or Discovery
  • Pre-clinical research
  • Clinical research
  • FDA review
  • Post-market safety monitoring by the FDA

The first phase typically involves the in-depth synthesis and screening of a drug that is intended for mass production. Animal testing forms the basis of this phase as it is used to check the toxicity of the said drug before it can be moved to human trials. To make the results efficient, the tests are carried out across a wide range of animal species. This phase is the primary level of information gathering on how the compound works, its efficiency, and safety.

After animal testing, the sponsor is free to make an IND (Investigation New Drug) Application. This application is directly based on the prior testing phase outcomes and contains information on manufacturing, compound chemistry, and the plan to be followed for human trials. The FDA reviews this application to ensure that the clinical trials on humans will pose no apparent dangers. They also ensure that the subjects are informed of the nature of the trials in order to protect them.

The first phase of clinical trials focuses on drug safety. This phase involves a focused and closely monitored testing process on healthy volunteers, usually between 20 and 80 in number. This step takes a look at how the compound is metabolized and excreted by the body alongside its accompanying side effects. The second phase of clinical trials involves even more test subjects. It is tailored to see how effective the drug is in its intended work. The drug is administered to subjects with the relevant condition or disease the compound is meant to treat. It may also involve the comparison of this drug’s effectiveness with other similar drugs. The third clinical trial phase is large scale and cements the information from the first two phases. It also shows drug information along with demographics, dosages, and contraindications.

After a review meeting between the sponsors and the FDA, they are allowed to submit a New Drug Application (NDA), alongside all the collected information from testing, to seek approval for marketing their product. The agency is expected to make a decision to initiate a review within 60 days of submission. If the NDA files the application, a team is assembled to review the manufacturer’s research information.

The drugs’ professional labeling is reviewed next, and the relevant information is communicated to consumers and relevant healthcare experts. This is followed by an FDA inspection of all the facilities intended for manufacturing the specified drug or device. The FDA finally decides to either approve the NDA application or not. If not, the drug sponsor receives an appropriate response letter. The drug is then available for prescription. The manufacturer, through MedWatch, is expected to report any cases of adverse reactions. The FDA also carries out post-market studies to get long-term information on the drug and re-determine its viability.

Drug labelling expert

Product labeling is a vital part of the FDA process as it acts as the user manual for the relevant medical device or drug. The FDA uses this labeling to outline their up-to-date findings on the relevant product’s safety and efficiency. Drug labeling typically contains the administration methods, doses, precautions, warnings, overdose instructions, information on abuse and dependence, storage, uses, and clinical pharmacology. This information is vital when prescribing medication or treatment for patients.

Proper labeling should be effective in conveying the necessary and updated information on the product to relevant physicians. The quality of this process, therefore, calls for the use of specific labeling language. Drug labeling experts can precisely evaluate the language on these labels and what they indicate or intend. These experts are also required to testify to these clinical summaries during this exercise to allow it to receive FDA approval alongside the actual drug.

The FDA drug label is always being updated, and the updated documents are expected to be distributed with every single stock bottle from the manufacturer. These experts ensure the manufacturers have made the necessary updates to these documents and are supplying the correctly updated copies along with their products.