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  2. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    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.

  3. Drug labelling - Wikipedia

    en.wikipedia.org/wiki/Drug_Labelling

    The details of label includes the name of preparation, quantity of drugs, instructions for patients, patient's name and the date of dispensing. Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify ...

  4. Boxed warning - Wikipedia

    en.wikipedia.org/wiki/Boxed_warning

    In April 2005, FDA advisors requested that Pfizer place a boxed warning on their non-steroidal anti-inflammatory drug Celebrex for cardiovascular and gastrointestinal risks. [9] [10] In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory was ...

  5. Structured Product Labeling - Wikipedia

    en.wikipedia.org/wiki/Structured_Product_Labeling

    Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.

  6. Medical prescription - Wikipedia

    en.wikipedia.org/wiki/Medical_prescription

    Pharmacy information systems are a potential source of valuable information for pharmaceutical companies as it contains information about the prescriber's prescribing habits. Prescription data mining of such data is a developing, specialized field. [59] Many prescribers lack the digitized information systems that reduce prescribing errors. [60]

  7. Investigator's brochure - Wikipedia

    en.wikipedia.org/wiki/Investigator's_brochure

    Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product". [2] The sponsor is responsible for keeping the information in the IB up-to-date.

  8. Food and Drug Administration Safety and Innovation Act

    en.wikipedia.org/wiki/Food_and_Drug...

    The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.

  9. Drug packaging - Wikipedia

    en.wikipedia.org/wiki/Drug_packaging

    Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, [1] uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation ...