Labelling changes

In 1966 the PDA utilized the services of the National Academy of Sciences—National Research Council (NAS—NRC) to estabhsh the relative therapeutic efficacies of prescription dmgs marketed between 1938 and 1962. Those products that were found to meet safety and efficacy requirements were allowed to stay on the market. Suitable changes were required for other products for compliance, ie, formulation or label changes, additional data... 

Labeling Supplement = all label change supplements required under 21 CFR 314.70 and 21 CFR 601.12 that do not qualify as efficacy supplements ... 

Moreover, in March 2007 the FDA requested label changes for all sleep disorder drug products from the manufacturers, to strengthen and expand the language concerning potential risks [11]. 

A periodic report contains certain information, such as the event terms submitted during the period, the dates that events of the period were submitted, an event term count by body system, and labeling changes made due to the period s adverse experiences. In addition to (and prior to) being incorporated into a periodic report, 15-day reports are submitted within 15 calendar days of the date the applicant received the data. All 15-day reports contain serious, unexpected events. Non-15-day reports are submitted periodically in FDA periodic reports. 

Approximately 10% of new chemical entities (NCEs) show serious adverse drug reactions (ADRs) after market launch. Such events usually result in new black box warnings by the US Food and Drug Administration (FDA), label change or market withdrawal. The most common causes for these actions are hepatic toxicity, hematologic toxicity and cardiovascular toxicity [2], Reasons for such ADRs, which are identified only after NCEs are launched on the market, include the narrow spectrum of clinical disorders and participating patient profiles in clinical studies as well as the fact that serious ADRs are often rare and that the number of patient exposures required to identify such occurrences sometimes may range over a few millions [3],... 

The new formatting process will support health information management technologies and accelerate the process of label changes. Thus, advancing the time it takes to get to the information to physician and patients. This process is only required for labeling sections or data information that has changed. 

Electronic labeling information will improve the drug-labeling review process and speed up the approval and public disseminahon of labeling changes, getting important, up-to-date informahon on medicahons to doctors and pahents more quickly. 

For submission of labeling changes, only the labeling sections or data elements that have changed need to be submitted. 

The aims of causality assessment are manifold. Adverse events need to be classified, a decision needs to be made whether a drug has caused this event, regulatory requirements need to be satisfied, signal recognition can be aided, and finally, at the end of this process, a label change may be necessary. 

FDA (2006) FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers. FDA News, http //www.fda. gov/bbs/topics/ NEWS/2006/ NEW01533.html (accessed May 28th, 2007). 

The first action intended to improve labeling from the standpoint of pediatric use information was the creation in 1979 (FDA, 1979) of the Pediatric Use subsection under the Precautions section of labeling. The final rule for this labeling change reaffirmed the need for substantial evidence from adequate and well-controlled trials in support of any new pediatric indications, and in the absence of such evidence, it called for the standard disclaimer, i.e., that safety and effectiveness in children have not been established. Unfortunately, the creation of this subsection by itself did not serve as an effective stimulus to pediatric drug research, and most... 

As of the date of this chapter (circa March, 2002), labeling changes regarding pediatric use have resulted from only two programs—the study of buspirone in pediatric GAD and a pharmacokinetic study of fluvoxamine in pediatric OCD (fluvoxamine already had a controlled clinical trial in pediatric patients). Two placebo-controlled trials with buspirone in pediatric GAD did not reveal a treatment effect, and this negative outcome is reflected in Buspar labeling. A pharmacokinetic study of fluvoxamine dosed at 100 mg bid in pediatric... 

Figure 4.3 E-pH diagram for Ag species. Soluble species concentrations (except H+) = 10 M. Soluble species and most solids are hydrated. No agents producing complexes or insoluble compounds are present other than HOH, OH , and Cl . Ag+ label changed to AgCl (see text).

Labeling changes, normally classified as major changes, that FDA specifically requests be implemented using a changes being effected supplement. 

Foreign language versions of the labeling, if no change is made to the content of the approved labeling and a certified translation is included. Labeling changes made to comply with an official compendium. 

The Environmental Protection Agency (EPA) may be advised of the desirability of requiring a label change, (2) a use regulation may be enacted which will have the same effect as a label change, (3) the use of the product may be restricted,... 

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