Text of Fda guidance for food and drug labelling professor pirouzi
1. This lecture is regarding compliance for post-marketing activities for updating the product label(U.S.) or the Summary of Product Characteristics (SmPC - EMEA) based on product related post-market updates on new indications, target populations, post marketing Safety data, productEfficacy and pharmacology data.
2. A new FDA final rule, "Requirements on Content and Format of Labelling for Human Prescription Drug and Biological Products," became effective in June 2006. The rule is part of FDAs initiative to manage the risks of medical product use and minimize adverse events. The new labelling reorders and reorganizes sections found in the previous labelling format. FDA has designed new labelling to help health care practitioners easily find, read, and convey information important for the safe and effective use of prescription drugs.
3. A label is now divided into highlights of prescribing information, contents of the full prescribing information (FPI), and the FPI. The highlights section is a half-page summary of the information that health care practitioners most commonly refer to and view as most important.
4. FDA has instituted a flexible implementation schedule that phases in the new labelling requirements; more time to achieve compliance is provided for older products. The revision of labelling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labelling of the listed drug referenced in the ANDA. The new requirements do not apply to nonprescription drug products.
5. A prescription drug product label (also known as a professional label, package insert, direction circular, and package circular) is a compilation of information about a product written by the manufacturer and approved by FDA. Labelling is based on the agencys thorough analysis of the new drug application (NDA) or biological license application. The labelling, or prescribing information, is thus subject to FDA regulations and is a requirement for all approved drug and biological drug products. A label contains information necessary for safe and effective use and is written primarily for the health care practitioner.
6. Confusing medical information maybe contributing to the approximately 300,000 preventable adverse events occurring each year in U. S. Hospitals. Research has shown that these adverse events may be reduced by prioritizing the warning information on the label. Based on multiple public meetings and surveys, FDA identified the most common ways practitioners use prescription drug labelling and the prescribing information they consider most important and applied its findings to the revisions.
7. The new labelling reorders and reorganizes sections found in the previous labelling format (next slide). Under the new system, a label is divided into highlights of prescribing information, contents of the full prescribing information (FPI), and the FPI.
8. Comparison of previous labelling format with revised format. (Subheadings may vary for
9. A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (next slide). This section provides immediate access to the information most crucial for a drugs safe and effective use and contains numerical cross-references to more details in the FPI. In designing the highlights section, FDA used established techniques to enhance the communication of large amounts of complex information. Highlights summarizes the information from the FPI that is most important for prescribing a drug safely and effectively and logically organizes it to enhance accessibility and retention. The design combines multiple textual and graphic elements (e.g., tables, bulleted lists, boldface, italics).
10. Example of highlights section (for a fictitious drug).
11. Highlights does not include all the information necessary to use a drug safely and effectively. For this reason, it is prefaced with a limitations statement that reads, "These highlights do not include all the information needed to use drug X safely and effectively. See full prescribing information for drug X. "
12. Product Names and Date of Initial FDA Approval. The listing of other names for the product can be important to avoid confusion. The date of approval provides context on the relative newness of a product, since there may be limited clinical information about a new product compared with one that has been on the market for some time. Boxed Warning. Many drug product labels contain a boxed warning, often referred to by health care practitioners as a black-box warning, to emphasize certain risks. The boxed warning that appears in the highlights section may be a condensed version of the complete boxed warning in the FPI and is limited to 20 lines. Cross-references maybe made to additional safety information in the FPI. Recent Major Changes. Changes that have been made to certain sections of the FPI are listed. Marginal notations appear in the corresponding sections of the FPI to indicate where the changes occurred. Indications and Usage. Listed are the indications for use of a drug, the major limitations to use, the pharmacologic class, and the mechanism of action.
13. Dosage and administration. The recommended dosage regimen for the given indications is provided, along with the starting dosage, dosage range, whether the drug should be taken with or without food, critical differences among population subsets, monitoring recommendations, and significant clinical pharmacologic information. Dosage Forms and Strengths. The available dosage forms and strengths are detailed. Contraindications. No relative contraindications are listed, only circumstances when the drug should absolutely not be used. The contraindications statement must be included even if there are no contraindications. Warnings and Precautions. An abbreviated summary of the most clinically significant adverse drug reactions (ADRs), how to monitor them, and how to treat them is provided.
14. Adverse Reactions. Listed are the most common ADRs, their frequencies, and how they should be reported to the manufacturer and to FDA. Drug Interactions. The drug interactions are briefly described. Use in Specific Populations. This section, which was previously integrated into the precautions section, summarizes important information about use in specific populations. Patient Counseling Information. The practitioner is reminded of information important to convey to the patient. Contents. The contents section serves as a navigational tool that references all the sections and subsections in the FPI, some of which may not be referenced in highlights (Figure 3). The contents sectional so allows for hyperlinks in electronic formats.
15. Changes in Content. The clinical pharmacology section describes drug-drug interaction study results and alerts practitioners to the extent of particular interactions. The contraindications section now describes only known hazards and no longer includes the statement "allergic to any component of the drug." A contraindication exists only when the risk from use clearly outweighs any possible therapeutic benefit. None is stated when no contraindications are known, and no relative or hypothetical contraindications are listed. The order in which contraindications are listed is based on their likelihood and the size of the population affected. The warni