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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) Search 16. OMUF OTC Monographs@FDA 17. Outsourcing Facility Product Report. 18. Postmarket Requirements and Commitments Search 19. PEPFAR President's Emergency Plan for AIDS Relief (PEPFAR) Database 20. Product-Specific Guidances for Generic Drug Development Database 21.
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
Litifilimab is an investigational drug being evaluated for the treatment of cutaneous lupus erythematosus and systemic lupus erythematosus. It is an anti- BDCA2 monocolonal antibody. [ 1 ] [ 2 ] [ 3 ]
Template parameters [Edit template data] This template has custom formatting. Parameter Description Type Status; Drug name: drug_name: Name of the drug, medication, or vaccine, including combination drugs. The article title will be used if this is left blank. String: suggested: type: type
This is a list of investigational analgesics, or analgesics that are currently under development for clinical use but are not yet approved. Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses. This list was last comprehensively updated in June 2017. It is likely to become outdated ...
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