Investigational products labeling

Sample of labels attached to investigational product containers... 

In this investigation, a labelled donor solvent was used to determine which structural positions in the coal products incorporate deuterium and to investigate the exchange of protium in the coal with deuterium in the donor solvent. It is important to understand this fundamental chemistry because a number of pilot plants use donor solvents (15-17). The yields of liquefied coal products may be improved through a detailed understanding of the hydrogenation mechanisms. 

There are five fundamental elements of FDA regulation of medical devices (1) facility registration and product listing (2) safe use of investigational devices (3) premarket notification (unless exempt) and product labeling ... 

Product label research use Product label investigational use Product label in vitro diagnostic use... 

Indications vary considerably and many indications listed here are not in the U.S. product labeling for each drug optimal use of these drugs alone or in combination with each other continues to be investigated. 

Manufacturing, Packaging, Labeling, and Coding Investigational Product(s)... 

Having classihed the IMBP based on its effects on immune function, the next and hnal step would be to make a risk assessment and to communicate the risk to physicians and to the patients receiving therapeutic doses of the IMBP. This can be accomplished through the existing mechanisms of the Investigator s Brochure, Informed Consent documents, and ultimately, the product label. 

The position of labelling must be chosen in such a way that the products of metabolism can be identified, e.g. by labelling with T or " C in the side chain of an aromatic compound if the fate of the side chain is of interest, or labelling in the aromatic part of the molecule if this is the main object of investigation. Double labelling, for instance by T and " C at different positions, is often very helpful. 

Reprints must be accompanied by the product labelling, a bibliography of additional articles (reports of clinical investigations, both supporting and not supporting the new use, that have been previously published in a scientific reference publication or scientific journal) unless the reprint already contains a bibliography, and any additional information required by the FDA. 

An adverse event is unexpected when its nature or severity is not consistent with information in the relevant source document(s) . Relevant source documents include the investigator s brochure for investigational drugs, and the master data sheet or core safety data sheet, or local product labeling for marketed products. The determination of whether an adverse event is unexpected usually resides with the company that sponsors the clinical trial or markets the product. 

Labelling developed specifically for products involved in a clinical trial. investigational product (synonym study product)... 

Crowley and Rapoport have made a detailed investigation, including labeling studies, of the reaction, both with one carboxylic function attached to a resin, and in solution with the carboxylic functions esteri-fied by different alcohols. Cyclization of the resin-attached methyl (51 R = Me) or r-butyl ester (51 R = Bu ) with BuOK gave the methyl (52 R = Me) or r-butyl 2-oxocarboxylates (52 R s Bu ) as the exclusive autocleaved product. Similar results were obtained with the half-benzyl esters in solution but the products were less readily isolated (equation 22). 

The packaging and labelling of investigational products are likely to be more complex and more liable to errors (which are also harder to detect) when blinded labels are used than for licensed products. Supervisory procedures such as label reconciliation, line clearance, etc., and the independent checks by quality control staff should accordingly be intensified. 

---