Fast Track Development Program
Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation typically enables a Company to submit a New Drug Application (NDA) on a “rolling” basis with ongoing FDA review during the submission process. NDAs with Fast Track designation are also usually granted priority review by FDA at the time of submission.
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Special Protocol Assessment
A Special Protocol Assessment (SPA) from the FDA is an agreement that the Phase III trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval. An SPA is binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing is begun.
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Abbreviated New Drug Application
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
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Investigational New Drug
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.
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New Drug Application (NDA)
Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:
* Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
* Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
* Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
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 are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.
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Approval Process for Medical Devices(510(k) or PMA process):
A medical device, according to the U.S. Food and Drug Administration (FDA), is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
* recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
* intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in human or other animals, or
* intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Generally, medical devices are split into 3 categories.
* Class I: Devices that do not require premarket approval or clearance but must follow general controls. Dental floss is a class I device.
* Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, and amalgam alloys used to fill cavities are all class II devices. The "predicate device" in question is often quite different, and this process is largely used to clear devices for marketing which do not meet the criteria to be considered class III. Hearing aids are class II devices.
* Class III: Devices that are approved by the Premarket Approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An artificial heart meets both criteria. The most commonly recognized class III device is an Automated External Defibrillator. Devices that do not meet either criterion are generally cleared as class II devices. They can also market the product as FDA approved, whereas, class II devices are not allowed this freedom.
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What are the phases of clinical trials?
From ClinicalTrials.gov,
"Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use."
- Sometimes pharmacokinetic studies are referred to as PK studies.
- There are different flavors of Phase I and II's, like Phase IIa or Phase Ib. They have different purposes like dosing finding, short-term safety, and a few others.
- It is usually best if the trials are randomized-controlled clinical trials, more robust data than other types of studies.
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Good references :
[1] http://en.wikipedia.org/wiki/Clinical_trial
[2] http://clinicaltrials.gov/ct2/info/understand
[3] http://www.cancer.gov/clinicaltrials/education/basicworkbook/page3
[4] http://clinicaltrials.gov/ct2/info/glossary
