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Etretinate (trade name Tegison) is a medication developed by Hoffmann–La Roche that was approved by the FDA in 1986 to treat severe psoriasis. It is a second-generation retinoid. [2] It was subsequently removed from the Canadian market in 1996 and the United States market in 1998 due to the high risk of birth defects.
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.
Therapeutic, diagnostic and preventive monoclonal antibodies are clones of a single parent cell. When used as drugs, the International Nonproprietary Names (INNs) end in -mab.
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...
Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants ...
The HSE was created by the Health and Safety at Work etc. Act 1974, and has since absorbed earlier regulatory bodies such as the Factory Inspectorate and the Railway Inspectorate though the Railway Inspectorate was transferred to the Office of Rail and Road in April 2006. [3] The HSE is sponsored by the Department for Work and Pensions.
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 ...
The Consumer Health Product Database is a web-based application that allows the public to search for specific products or specific chemical ingredients. It is a collection of publicly available information, mostly from product labels and Safety Data Sheets (former MSDS) provided by the product's manufacturer. [1]