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Prescription drug monitoring programs, or PDMPs, are an example of one initiative proposed to alleviate effects of the opioid crisis. [1] The programs are designed to restrict prescription drug abuse by limiting a patient's ability to obtain similar prescriptions from multiple providers (i.e. “doctor shopping”) and reducing diversion of controlled substances.
Description. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.
New Drug Application. The Food and Drug Administration 's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [1][2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of 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.
t. e. Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.
Waivers are considered on a case-by-case basis under specific conditions, including cases where the applicant is competitive for an offer of appointment, awarded a scholarship, or meets particular performance standards in a campus-based ROTC program. The medical waiver authorities are designated by the Academies, ROTC programs, USUHS, and ...
Electronic prescription (e-prescribing or e-Rx) is the computer-based electronic generation, transmission, and filling of a medical prescription, taking the place of paper and faxed prescriptions. E-prescribing allows a physician, physician assistant, pharmacist, or nurse practitioner to use digital prescription software to electronically ...
Investigator's brochure. 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 ...