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(Reuters) -The U.S. health regulator on Monday asked a host of drugmakers, including Gilead Sciences, Johnson & Johnson and Novartis, to add a serious warning on the label of their cancer ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...
The drugmaker, which can't seem to get its act straight lately, last week received a warning letter from the U.S. Food and Drug. Another day, another Johnson & Johnson (JNJ) news item -- and once ...
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The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
The FDA pointed to deficiencies in cleaning and maintenance of equipment to prevent contamination of drug product and also recommended the company review its quality control process, Emergent said.