Search results
Results from the WOW.Com Content Network
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [ 1 ]
An example SDS, including guidance for handling a hazardous substance and information on its composition and properties. A safety data sheet (SDS), [1] material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products.
The Hazardous Substances Data Bank (HSDB) was a toxicology database on the U.S. National Library of Medicine's (NLM) Toxicology Data Network (TOXNET). [2] [3] It focused on the toxicology of potentially hazardous chemicals, and included information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, and related areas.
The FDA launched a new program in 2005 to provide drug risk information directly to the public through internet-accessible drug sheets and bulletins. [30] The enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA), [ 31 ] expanded the authority of the FDA over drug safety monitoring after approval and introduction for use ...
Herpes simplex encephalitis (HSE), or simply herpes encephalitis, is encephalitis due to herpes simplex virus. It is estimated to affect at least 1 in 500,000 individuals per year, [ 1 ] and some studies suggest an incidence rate of 5.9 cases per 100,000 live births.
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.
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
In August 2020, the NIAID started the Adaptive COVID‑19 Treatment Trial 3 (ACTT 3) to evaluate the safety and efficacy of a treatment regimen consisting of remdesivir plus interferon beta-1a for hospitalized adults who have a laboratory-confirmed SARS-CoV-2 infection with evidence of lung involvement, including a need for supplemental oxygen ...