Labeling claims

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Label claims for tocopherol levels in preparations can be based on milligrams or International Units. Only the RRR or all-rac-International Units ate also used in some reference books and compendia, eg. Food Chemicals Codex (40,53), which is of particular importance for specifications for food fortification. 

The content uniformity is within the accepted range (1.93% is less than 6% CV maximum one out of ten values is outside the 85-115% range, but within the 75-125% range no value below 75 or above 125% of label claim. 

Assay 90-110% of label claim (pick 20 tablets at random grind and mix weigh an amount of powder corresponding to five tablets dissolve compound sample and centrifuge excipients run a HPLC analysis on an aliquot of the supernatant), and... 

Content uniformity Nine out of 10 randomly picked and individually analyzed tablets must yield drug contents between 85 and 115% of label claim all 10 results must be within 75-125% of label claim. 

For regulatory purposes, food-based RMs play an important role in validating accuracy of analytical data from use of routine methodology. For example, the quality of data obtained by analytical measurements serves an important function with regard to ensuring nutritional label claims. Unfortunately, and historically in some cases, assay data for the same analyte can vary greatly from laboratory to laboratory. Evalua-... 

Treatment Sample Percent label claim by peak area (w/v) Percent label claim by peak height (w/v) Mw (1 x 104) Hi (1 x 104) P... 

Content uniformity is a USP test is designed to establish the homogeneity of a batch. Ten tablets are assayed individually after which the arithmetic mean and relative standard deviation (RSD) are calculated. USP criteria are met if the content uniformity lies within 85-115% of the label claim and the RSD is not greater than 6%. Provision is included in the compendium for additional testing if one or more units fail to meet the standards. 

The FDA evaluates each tumor marker test against its own labeling claims as to how well it performs and compares it with other cleared and marketed devices identified in the 510(k) submission. The intended use claim for monitoring must be supported by valid scientific and clinical data. Labeling a tumor marker test for a particular claim can mean that the testing system may have to show supporting data for that claim. For example, a tumor marker proposed for a monitoring claim will require laboratory and clinical data to support that claim (4,5). 

On the other hand, for the standard addition method, the spiking concentrations are in the range of 50-150% of the label-claimed value, and are made by spiking of known analyte concentrations in matrices such as serum, plasma, etc. 

Passage of the Sherley Amendment. Specifically outlawed any false label claims as to curative effect. 

The method for the evaluation of similarity of dissolution profiles depends on dissolution characteristic of the reference and test drug product. If both formulations (average value of n = 12 each) dissolve at least 85% of label claim within 15 min, dissolution profiles are generally assumed as similar and no further testing or data analysis is required. 

Gurley, B.J. et al.. Content versus label claims in ephedra-containing dietary supplements. Am. 

The assay of potency involves the determination of the API to ensure conformance to label claim. For tablets or capsules, a composite assay requires fO-20 units to minimize tablet-to-tablet variation. In assays, it is critical for the quantitative extraction and recovery of the API meet the typical specification limit between 90.0% and 110.0% of label claim. 

No. Intact Crushed Sonication Shaking % Label claim... 

The method yielded >99% label claim of the API for the composite tablet assay. Table 3 lists the results of a filter validation study showing the quantitative recovery of the API from most membrane media. 

Methods for the quantitation of major components of bulk drug substances or APIs, including preservatives, in finished drug products are classified in Category I. Assay and content uniformity methods fall into this category. These methods demonstrate that the label claim of the drug... 

Of the four pharmacopeias, the U.S. pharmacopeia (USP) has the strietest requirements for delivered dose uniformity. Although the British pharmaeopeia (BP) allows the same performance range, the USP defines the range around the label claim and the BP defines the range around the average value. The FDA expeetation for delivered dose uniformity is currently tighter than that stated in all the pharmaeopeias. 

---