Food and Drug Administrations

Approval Process for Prescription Drugs

and Medical Devices

Table of Contents
Introduction............................................................................................................................................. 1
Prescription Medication ........................................................................................................................... 1
Prescription Drug Applications ............................................................................................................ 1
FDA Approval of Prescription Drugs ................................................................................................... 2

Medical Devices ...................................................................................................................................... 2

What is a Medical Device? .................................................................................................................. 2
Medical Device FDA Applications and Approvals ............................................................................... 3

FDAs Accelerated Approval Program .................................................................................................... 3

Controversies with the Accelerated Approval Program ........................................................................ 3

Works Cited ............................................................................................................................................ 4

Introduction
Food and Drug Administration (FDA) approval is required to sell medical devices and
prescription drugs in the United States of America. To get FDA approval there are several steps
and processes that have to be done including packaging, warning labels, product testing and
trials.

Prescription Medication
To get a prescription drug approved by the FDA the product has to go through phases of testing.
The drug must go through laboratory and animal testing to prove that it is safe for human
consumption. Then the drug must be tested on humans in a controlled environment to prove that
it is safe and effective for distribution nationally.

Prescription Drug Applications

Once there is proof that the drug is safe for distribution the next step is to fill out an application.
The following are the various types of drug applications available:

Investigational New Drug (IND) Applications:

o An Investigator IND - Is typically submitted by a physician who wants to get the
drug approved. The physician may submit a research IND for the purpose of
studying an unapproved drug or to prove that the drug can serve another purpose
in treating a different illness or disease.
o Emergency Use IND Is done when then FDA allows the drug to be administered
in an emergency situation. This application is also used for patients who do not
meet the criteria to be in an existing controlled study. This application can also be
used if the approved study does not have a protocol.
o Treatment IND This application is used when a patient is in a life threatening
situation and the drug in question is in the final stages of FDA approval.
New Drug Application (NDA) This application is used to approve new drugs for the
administration and distribution within the United States of America. The application must
contain the following information about the new drug before it is approved:
o Chemistry
o Biopharmaceutics
o Statistics
o Pharmacology
o Medical
Abbreviated New Drug Application (ANDA) This application is used for FDA
approval of generic drugs. Generic drug applications arent required to include preclinical
(animal) and clinical (human) data. This application must prove that the generic drug is
as effective as the innovator drug.

Biologic License Application (BLA) This application is used for drugs that are
composed of biological products. Applicants must elaborate on the following categories
concerning the drug in the application:
o Manufacturing processes
o clinical pharmacology
o Chemistry
o medical affects
o Pharmacology

With each application you must include the following information:

Results from the drug testing

Plans for distribution and manufacturing
Label for packaging

The results of the drug testing must be included to ensure that the product has been thoroughly
tested and is ready for manufacturing. The plans for manufacturing is pertinent to ensure that the
proposed company has the ability to safely manufacture the drug. The label for the drug provides
necessary information to the public including the medical condition that the drug remedies,
instruction for ingestion, ingredients and possible risks.

FDA Approval of Prescription Drugs

Approval is dependent on a review by FDA physicians and scientists. If the drugs benefits
outweigh its known risks and the drug can be manufactured in a way that ensures a quality
product, the drug is approved and can be marketed in the United States.

Medical Devices
Medical devices are regulated by the FDAs center for Devices and Radiological Health
(CDRH). This is done whether the companies are designing, importing, relabeling or
repackaging the medical device(s).

What is a Medical Device?

Medical devices regulated by the FDA include devices that are recognized in the official
National Formulary or the United States Pharmacopoeia. This includes devices that are generally
used to diagnose, cure, mitigate, treat or prevent disease or other conditions in humans or
animals. Devices that are intended to influence the structure or function of the body without the
help of any substance that can be ingested or metabolized in humans or animals are included in
the list.
Medical devices by definition include the following structures:

Instrument
Apparatus
Implement
Machine

Contrivance
Implant
In vitro reagent

Medical Device FDA Applications and Approvals

There are two types of FDA applications for medical devices:

Premarket Notification (510(k))

Premarket Approval (PMA)

Knowing which application to send in is dependent on the classification of the medical device. If
you are acquiring a clearance for a device that is already legally marketed for the same use you
must submit a 510(k). For this to be approved the application must show that the device is able to
perform at the same level of its equivalent.
The PMA application is necessary if you are acquiring FDA approval of a new device. The
application must demonstrate that the medical device is up to federal regulated standards and that
the device is effective.

FDAs Accelerated Approval Program

The FDA composed the Accelerated Approval Program in 1992. This program was designed to
expedite the approval of life-saving drugs and devices. Unlike the standard approval program
which focuses on the results of the lengthy clinical trials, the FDA Accelerated Approval
Program focuses on a measurement called a surrogate endpoint.
A surrogate endpoint is the indicating factor that explores the potential for a positive long-term
clinical outcome, or endpoint. The goal of this program is to measure the impact the drug or
device has on a short term level in order to approve the drug or device for life saving measures.
If the drug succeeds in significantly impacting the health of the patients on trial it would qualify
for this approval program.

Controversies with the Accelerated Approval Program

The Accelerated Approval Program has often been criticized for accelerating drugs and devices
without sufficient evidence of their efficiency. Approximately ten percent of oncology drugs that
have been accelerated fail in their post-market studies. These drugs are distributed as a last resort
for critically ill patients. This inefficiency creates issues with possible side effects resulting in
deficiencies and even death.
Manufacturers who receive accelerated approval often postpone post-marketing studies. These
studies can reverse FDA approval if deemed necessary. In 2011 there were discussions of fines
for manufacturers who postpone post-marketing studies of up to ten million dollars.

Works Cited
Accelerated Approval Program . (n.d.). Retrieved from Drug Dangers:
http://www.drugdangers.com/fda/accelerated-approval-program.htm
Investigational New Drug Application. (2016, August 01). Retrieved from U.S. Food and Drug
Administration:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/appr
ovalapplications/investigationalnewdrugindapplication/default.htm
Medical Devices. (2015, July 7). Retrieved from U.S. Food and Drug Administration:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193731.htm
What Does it Mean When the FDA Clears or Approves a Medical Device. (2015, December 28).
Retrieved from U.S. Food and Drug Administration:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm
What is a Medical Device. (2015, December 28). Retrieved from U.S. Food and Drug Administration:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm
What is the Approval Process for a New Prescription Drug. (2016, May 12). Retrieved from U.S. Food
and Drug Administration: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194949.htm