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Drugs accelerated approval

For drugs approved under accelerated approval regulations on the basis of a surrogate endpoint or an endpoint other than survival or irreversible morbidity, FDA may require a Phase IV study to confirm the drug s efficacy. Failure to show efficacy may result in withdrawal of approval. [Pg.782]

FDA is able to rely on less well-established surrogates for accelerated approval of drugs that provide meaningful benefits over existing therapies for serious or life-threatening illnesses, such as AIDS, rare carcinomas, or breaking infectious diseases. In these cases, the... [Pg.344]

Food and Drug Administration. Accelerated Approvals, FDA, 21 CFR Parts 314.500 and 601.4. [Pg.276]

Despite the efforts of the ICH, the regulatory requirements in the different regions are still quite different. For instance, only the USA has the possibility for accelerated approval of drugs to treat life threatening or severely debilitating illnesses (so-called Subpart E drugs). [Pg.110]

Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available. [Pg.246]

Most drugs to treat HIV have been approved under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don t confirm the initial results, the FDA can withdraw the approval. [Pg.247]

The particular absorber to be used in a given application depends on several factors. One important criterion is whether the absorber will strongly absorb that portion of the ultraviolet spectrum responsible for degradation of the plastic under consideration. Compatibility, volatility, thermal stability, and interactions with other additives and fillers are other items that must be considered. When used in food wrappings, Food and Drug Administration approval must be obtained. While one or more of these considerations may rule out a given stabilizer or influence llie choice of one class over another, the final selection must await the results of extensive accelerated and long-term tests. [Pg.1641]

Accelerated drug approval program Mechanism to accelerate approval of products designed to treat life-threatening or seriously debilitating diseases based on modified criteria for marketing approval for example, the use of surrogate end points. [Pg.24]

Accelerated Approval—This is a program that the FDA developed to make new drug products available for life-threatening diseases when they appear to provide a benefit over available therapy (which could mean that there was no existing effective treatment). This guidance provides additional information http //www.fda.gov/cder/guidance/5645fnl.htm. [Pg.59]

Concurrently with an IND filing (or at any later time), a sponsor can request a fast-track product designation for its drug, provided the therapy addresses unmet medical needs related to a serious and life-threatening condition. This fast-track designation, which was created under the FDA Modernization Act of 1997, makes a product eligible for accelerated approval and other benefits. [Pg.1444]

Sub-Part H. The accelerated approval of new drugs for serious or life-threatening illnesses is provided for in 21CFR314.500-560 ( Sub-Part H ). This... [Pg.410]


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