The Drug Development Process

What are the 5 steps of the drug development process?

1. Discovery and Development

2. Preclinical Research

3. Clinical Research

4. FDA Review

5. FDA Post-Market Safety Monitoring

Why would a new drug need be to researched?

• New insights in a disease process that allow researchers to design a product to stop/reverse the effects of a disease

• Existing treatments had a unintended/unfavorable effect

• New tech that can allow new ways to target medical products to specific sites in the body

• new ways for genetic manipulation

What happens in preclinical research?

Drugs undergo laboratory and animal testing to answer basic questions about safety, and seeing if it can be used in humans for testing

What are the two types of preclinical research

In vitro, in vivo

What are Good Laboratory Practices?

regulations that set the minimum basic requirements for things like written protocols, equipment, study reports, etc. to assure product safety

What needs to happen before clinical research?

Developers of the clinical study needs to consider what they want to accomplish for each different clinical research phases AND submit an IND to the FDA

What is IND?

Investigational New Drug Process

What does IND do?

process developers of clinical studies need to go through before clinical research begins

What does the developer need to inform the FDA review team of the clinical trials?

• the new protocols of the clinical trial

• the side effects seen in clinical trial

• study reports from the clinical trial

How many days does the FDA have to review the original IND submission

30 days

What happens in clinical research?

Stage in which drugs are tested on people to make sure they're safe and effective, they refer to the studies/trials that are done in people.

Why does the FDA need to review the IND submission

To protect human volunteers from participating in unreasonable and risky trials

When does the process of the FDA reviewing the clinical trial and developers submitting study reports end?

• Developer wants to end clinical trials

• Developer wants to file a marketing application

What is required for the developer file a marketing application?

Enough data from 2 large, controlled clinical trials; the drug is proved to be safe and effective for its intended use based on evidence from early tests, preclinical trials and clinical research

What happens during the FDA reviews?

The review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve/not approve it.

What is a NDA?

New Drug Application

What does an NDA do?

Tells the full story of a drug, to show that a drug is safe and effective for its intended use in the population studied.

What does an NDA must include?

all data from all research stages; reports on all studies, data and analyses; clinical results; proposed labeling; safety updates; drug abuse info; patent info; directions for use; etc.

What can the FDA do with an NDA?

The review team decides if the NDA is complete. If not complete, the team can refuse to file it. If complete, the team has 6-10 months to make a decision onf the drug’s approval

What is the difference between an IND and an NDA?

IND review is to allow for clinical trial and testing on humans, NDA is allow for approval of a new drug for sale/marketing

What is labeling in the drug development process?

It is when the FDA works with an applicant to develop and refine prescribing info for a drug that is shown to be safe and effective for its intended use

Why is FDA post-market safety monitoring needed?

 because the true picture of a product's safety evolves overtime in the marketplace, and the FDA can review reports of issues with the drugs and can add cautions to the dosage/usage info