Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.
Most Frequently Asked Questions about the FDA Drug Approval Process
1. Why are drugs evaluated by the FDA?
Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research.
2. Does FDA test drugs?
No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists, and other scientist.
3. What are clinical trials and how do they relate to drug approval?
Clinical trials are studies that use human subjects (people) to see whether a drug is effective and what side effects it may cause. The trials are for gathering information about a drug that has not yet been proven to treat patients with a specific condition. A drug being studied in a clinical trial is called an investigational drug. Clinical trials of drugs provide information about:
4. How long does the drug approval process take?
The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review and Priority Review. Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review. Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
5. What are the different types of drug applications that can be submitted to FDA?
6. Do over-the-counter (OTC) medications go through the same approval process as prescription drugs?
No. Because there are over 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids. For each class, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application process. A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling.