monograph

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a detailed and documented treatise on a particular subject

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Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease.
It is divided into two parts; Part 1 is the A-Z Drug Monographs with clearly labelled alphabetical thumb tabs and coding to denote high alert drugs and Part 2 is the Drug Classification Tables, a resource which allows comparison within the different groups.
Once the OTC drug is eligible for the OTC drug monograph system, the sponsor submits safety and effectiveness data for evaluation to the FDA, which includes the official or proposed USP-NF monograph.
A drug manufacturer may wish to alter the conditions of use in an OTC drug monograph.
Each STEPh Report assesses the competitive landscape by individual drug monograph, mechanism of action, clinical trials data, projected launch year, company, and specific key issues.
The Epocrates Medical Information Team made the necessary changes to the Raptiva drug monograph and released it with an FDA MedWatch DocAlert message highlighting the withdrawal notice.
Each STEPh Report assesses the competitive landscape by individual drug monograph, MOA, clinical trials data, projected launch year, company, and specific key issues.
The MS STEPh Report assesses the competitive landscape by drug monograph, MOA, clinical data, projected launch year, company, and key issues.
This compliments drug monograph information delivered to our advocates when they complete their order.
Novation offers multiple clinical resources to the members it serves including the Drug Monograph Service and the biannual Drug Price Forecast.
Crane's extensive experience encompasses all phases of the marketing, labeling and distribution of both OTC drugs and dietary supplements, with special emphasis on the labeling requirements mandated in the OTC drug monographs and the associated format and content regulations.
8226; Overview of the OTC Drug Monographs and Their Importance
The full Nursing Drug Handbook app features drug monographs addressing more than 900 generic and nearly 3,000 brand name drugs.