Millions of Americans take drugs or medication of some kind every day, and every single product has been vetted before it came to market. The FDA’s Center for Drug Evaluation and Research (CDER) ensures all drugs marketed in the US are both effective and safe. Although the CDER does not actually conduct any drug testing itself, it undertakes extensive reviews of all new drugs submitted by pharmaceutical companies. In order to sell to the general public in the US, all drugs must undergo thorough testing by the manufacturer and be approved by the CDER.

How the FDA Approves New Drugs

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The CDER team includes a number of experienced chemists, statisticians, scientists and pharmacologists whose job it is to analyse all drugs before they can be sold to the public.

The FDA consists of six separate centres, and the CDER is the largest of these. As the FDA website explains, the CDER is responsible for ensuring the safety of all prescription and non-prescription drugs – the latter group is also known as over-the-counter drugs, meaning those that can be bought without a doctor’s prescription.

How Companies Submit New Drugs

When a company has a new drug it wishes to market, the company itself must conduct thorough tests to ensure it is effective for its intended purpose and is safe to take. The company must submit evidence to the CDER that proves thorough testing has taken place and that the drug is of the required standard. The CDER will then review all the available information, as well as analysing the company’s proposed labels.

How Drug Companies Can Ensure a Smooth Passage to Market

There are a number of private businesses that specialize in helping drug companies get their new products to market. Companies such as have a great deal of experience of working within the drugs industry and understand the nature of the CDER assessments and review processes. The advantage for drugs manufacturers of working with one of the many available companies to help with FDA 510k is that the time to market can be considerably reduced.

The cost savings a shorter time to market can yield are substantial, and specialist companies can use their experience to ensure the CDER’s review process goes smoothly. This has the added benefit of freeing up drug company staff for other tasks, minimizing inconvenience and cost to the manufacturer.