FDA Drug Review

This post is part of 'Domain | General' series

If a drug developer has evidence from its early tests and preclinical and clinical research that a drug is safe and effective for its intended use, the company can file an application to market the drug. The FDA review team thoroughly examines all submitted data on the drug and makes a decision to approve or not to approve it.

New Drug Application

A New Drug Application (NDA) tells the full story of a drug. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied.

A drug developer must include everything about a drug—from preclinical data to Phase 3 trial data—in an NDA. Developers must include reports on all studies, data, and analyses. Along with clinical results, developers must include:

  • Proposed labeling

  • Safety updates

  • Drug abuse information

  • Patent information

  • Any data from studies that may have been conducted outside the United States

  • Institutional review board compliance information

  • Directions for use

FDA Review

Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug. The process includes the following:

  • Each member of the review team conducts a full review of his or her section of the application. For example, the medical officer and the statistician review clinical data, while a pharmacologist reviews the data from animal studies. Within each technical discipline represented on the team, there is also a supervisory review.

  • FDA inspectors travel to clinical study sites to conduct a routine inspection. The Agency looks for evidence of fabrication, manipulation, or withholding of data.

  • The project manager assembles all individual reviews and other documents, such as the inspection report, into an “action package.” This document becomes the record for FDA review. The review team issues a recommendation, and a senior FDA official makes a decision.

FDA Approval

In cases where FDA determines that a drug has been shown to be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information. This is referred to as “labeling.” Labeling accurately and objectively describes the basis for approval and how best to use the drug.

Often, though, remaining issues need to be resolved before the drug can be approved for marketing. Sometimes FDA requires the developer to address questions based on existing data. In other cases, FDA requires additional studies. At this point, the developer can decide whether or not to continue further development. If a developer disagrees with an FDA decision, there are mechanisms for formal appeal.


source: fda.gov

Filter a category

List of other posts


What are CDISC standards?
What is a clinical development plan?
What is a clinical study report?
What is a clinical trial registry?
What is the importance of baseline characteristics in a clinical trial?
Drug discovery
Drug Development
Preclinical Research
The Investigational New Drug Process
What is ICH?
Efficacy data vs Safety data
What is a clinical trial?
Why are clinical trials conducted?
What is a clinical trial protocol?
Who conducts clinical trials?
Inclusion/Exclusion Criteria in a clinical trial
What are the phases of clinical trials?
What happens after a clinical trial is completed?
FDA Drug Review
Key steps in developing new drugs and biologicals

Trial design aspects
What is a crossover clinical trial?

What is a cohort?


What is a computer?
What happens when we execute a SAS program?
What is software?
What is SAS?
What is data?
What is data entry?
What is data retrieval?
What is data management?
What is "Report"?
What is statistics?
What is Statistical Analysis?
How do we use SAS?
What kind of questions can SAS help us answer?
How do we provide instructions to SAS?
What is a SAS program?
What does a SAS program contain?

Attributes of a SAS dataset
Rules for SAS dataset names
Rules for SAS variable names
Rules for SAS library names
Rules for character SAS format names
Reserved SAS dataset names
Rules for numeric SAS format names
What can SAS dataset options do?
Attributes of a SAS variable
Automatic conversion of data types in SAS
How does SAS expect our data to be organized?
Introduction to SAS interface
By groups in SAS

Rules for character SAS informat names

Proc freq
Count the number of times a particular value occurred in a variable of a dataset

Proc contents
Check the list of variables in a SAS dataset

Proc datasets
Delete all sas datasets from a library
Delete specific sas datasets from a library
Save specific sas datasets (and delete others) of a library
Rename SAS datasets using proc datasets change statement

Log issues
WARNING: No matching members in directory.

One-line definitions
What is a SAS library?
What is a libref?
What is an input statement?
What is infile statement?
What is set statement?
What is length statement?


How to derive baseline flag in SDTM
How to create SEQ variable in SDTM
New domains in SDTM IG 3.3
What is a codelist?
How to derive study day variable in SDTM
What is SDTM?
Why do we need SDTM?
How to convert original results to standard results using conversion factors

What information does SDTM.DM (Demographics) contain?

Adverse Events
What is causality assessment?
What information does SDTM.AE (Adverse Events) contain?

What information does SDTM.DS (Disposition) contain?

Concomitant Medications
What information does SDTM.CM (Concomitant/Prior Medications) contain?

What information does SDTM.PR (Procedures) contain?


What is ADaM?

What is ADSL as per ADaM standard?

What is BDS as per ADaM standard?


Alpha and beta errors
What is correlation?


What is R?
What is an R package?
What is tidyverse?
What are the core packages of tidyverse?
What is haven package of tidyverse?
How to install tidyverse?
How to load core tidyverse packages into the R session?

Reading data
Import/Read SAS dataset into R

Creating sample data
How to create some sample data in SAS and R tidyverse

Subset variables (columns)
How to select only required variables/columns in SAS and R tidyverse?
How to drop unwanted variables/columns in SAS and R tidyverse?

Subset observations (rows)
How to select/subset required rows in SAS and R tidyverse

Appending data
Append two datasets in SAS and R tidyverse

Merging/joining data
Merge/full join two datasets in SAS and R tidyverse
Merge/inner join two datasets in SAS and R tidyverse
Merge/left join two datasets in SAS and R tidyverse

Sort (order) observations
Sort/order observations based on the values in a single variable in SAS and R tidyverse

Transpose/Restructure data
Restructure/transpose long data to wide data
Restructure/transpose wide data to long data

Obtain frequencies
Obtain frequencies/counts based on one variable - one-way frequencies in SAS and R tidyverse
Obtain frequencies/counts based on two variables - two-way frequencies in SAS and R tidyverse

Descriptive statistics
Descriptive statistics for a numeric variable using SAS and R tidyverse