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News:

New drug application

U.S. drug regulation
Prescription drugs
Over-the-counter drugs
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The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:

  • Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks?
  • Is the drug’s proposed labeling (package insert) appropriate, and what should it contain?
  • Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?

Contents

Before Trials

To legally test the drug on human subjects in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA. This application is based on pre-clinical data, typically from animal studies, that shows the drug is safe enough to be tested in humans.

Often the "new" drugs that are submitted are not new molecular entities, but old medications that have been substantially modified or are used in new ways.

Clinical Trials

The legal requirement for approval is "substantial" evidence of efficacy demonstrated through controlled clinical trials. [1] This standard lies at the heart of the regulatory program for drugs. It means that the clinical experience of doctors, the opinion of experts, or testimonials from patients, even if they have experienced a miraculous recovery, have minimal weight in this process. Data for the submission must come from rigorous clinical trials.

The trials are typically conducted in three phases:

  • Phase 1: The drug is tested in a few healthy volunteers to determine if it is acutely toxic.
  • Phase 2: Various doses of the drug are tried to determine how much to give to patients.
  • Phase 3: The drug is typically tested in double-blind, placebo controlled trials to demonstrate that it works. Sponsors typically confer with FDA prior to starting these trials to determine what data is needed, since these trials often involve hundreds of patients and are very expensive.
  • (Phase 4): These are post-approval trials that are sometimes a condition attached by the FDA to the approval.

The legal requirements for safety and efficacy have been interpreted as requiring scientific evidence that the benefits of a drug outweigh the risks and that adequate instructions exist for use, since many drugs are toxic and technically not "safe" in the usual sense.

Many approved medications for serious illnesses (i.e. cancer) have severe and even life-threatening side effects. Even relatively safe and well understood OTC drugs such as aspirin can be dangerous if used incorrectly.

The actual application

The results of the testing program are codified in an FDA-approved public document that is called the product label, package insert or Full Prescribing Information. [2]The prescribing information is widely available on the web, from the FDA, [3]drug manufacturers, and frequently inserted into drug packages.The main purpose of a drug label is to provide doctors with adequate information and directions for the safe use of the drug.

The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug formulation are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the U.S.

Requirements for similar products

Biologics, such as vaccines and many recombinant proteins used in medical treatments are approved by FDA via a Biologic License Application (BLA), rather than an NDA. Manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process.

Generic drugs that have already been approved via an NDA submitted by another maker are approved via an Abbreviated New Drug Application (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA.[4] Biological drugs, including most recombinant proteins are considered ineligible for an ANDA under current US law.[5]

Medications intended for use in animals are submitted to a different center within FDA, the Center for Veterinary Medicine (CVM) in a New Animal Drug Application (NADA). These are also specifically evaluated for their use in food animals and their possible effect on the food from animals treated with the drug.

Medical devices are approved by a variety of methods depending on the class of the device. A Pre-market Application (PMA) largely equivalent to an NDA is required for class III devices, and a 510(k) approval that shows the device is equal to or better than a predicate device already on the market is required for class II devices. Class I medical devices (such as a toothbrush) do not require any approval at all.

References

  1. ^ Food, Drug, and Cosmetic Act, Section 502; 21 USC 355]
  2. ^ 21 CFR 201.5: Labeling Requirements for Prescription Drugs and/or Insulin
  3. ^ Daily Med: Current Medication Information. Retrieved on October 10, 2007.
  4. ^ FDA, CDER Office of Generic Drugs
  5. ^ Rouhi, A.M. “Beyond Hatch-Waxman: Legislative action seeks to close loopholes in U.S. law that delay entry of generics into the market” Chem & Eng News 80(38):53-59

See also

The original article is from Wikipedia. To view the original article please click here.
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