Markets history

Including indications for use, device description, aiternative practices and procedures currentiy avaiiabie for the condition, marketing history (US or foreign) non-ciinical laboratory studies, clinical investigations and overall conclusions. 

As evidence of prior human use, documentation of marketing history (with volume of sales) and review of past and current references, compendia, and literatures should be provided. It is understandable that many of these publications are in variable format and quality, and often do not consist of modern scientific data. In this respect, the Agency will accept all types of documentation for consideration and determine the validity of support in individual cases. 

Some safety issues for excipients with a history of use may be addressed by citations of the clinical and nonclinical database, marketing history, or regulatory status of the compound, e.g., GRAS status as a direct food additive may support oral administration of that product up to the levels allowed in foods. 

In a recent article, the FDA stated For excipients with a history of use, it may be possible to adequately address some or all of the safety issues through citation of the existing nonclinical and clinical database, marketing history, or regulatory status of the compound (e.g., GRAS status as a direct food additive may adequately support oral administration of that compound up to the levels permitted in foods) (25). Therefore, it appears reasonable that the FDA would consider the use safety data based on the food additive regulatory status of an excipient to evaluate the safety of the excipient. If a new excipient has undergone a food additive safety review, this may reduce the perceived risks associated with the development and use of a new excipient. 

Foreign marketing history Chemistry, manufacturing, and controls summary Nonclinical pharmacology and toxicology summary Human pharmacokinetic and bioavailability summary Microbiology summary... 

Summary of regulatory status and marketing history in the United States and foreign countries... 

In use tests represent a very valuable tool in the assessment armory. Many personal care products are designed for frequent skin contact, often with very sensitive areas of skin (e.g., the face or underarm). Materials such as face creams and deodorants, etc. must therefore be evaluated for their irritation potential to ensure that they are safe for normal use. A use or exaggerated use test provides data on which a safety assessment can be made. A test material is compared with a control, usually a material of similar formulation that is already marketed, and has an acceptable market history. The frequency of exposure may be exaggerated to maximize the sensitivity of the test. For the duration of the test, panellists are provided with test and control materials and a treatment card to record the daily use of each material. The materials issued at the start of the test are weighed before and after the test, so that the amount of material used can be calculated. 

The summary should avoid any editorial promotion of the product, i.e., it should be a factual summary of safety and effectiveness data and a neutral analysis of these data. The summary should include an annotated copy of the proposed labeling, a discussion of the product s benefits and risks, a description of the foreign marketing history of the drug (if any), and a summary of each technical section. 

Description of drug and formulation Annotated draft insert Product pharmacologic class Scientific rationale for use of product Clinical benefits Foreign marketing history CMC summary... 

The mattress market history provides an interesting view of one industry s response to the forced introduction of a flammability standard. The message of adaptation, rather than complete change, is perhaps a preview of the future for the furniture industry. Whatever the combination of fabric and construction, industry recognizes the importance of these variables in the overall assessment of fire risk and has adapted manufacturing to reduce fire hazards. 

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