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Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
Medicare Prescription Drug, Improvement, and Modernization Act; Long title: An act to amend title XVIII of the Social Security Act to provide for a voluntary prescription drug benefit under the medicare program and to strengthen and improve the medicare program, and for other purposes. Acronyms (colloquial) Medicare Modernization Act or MMA ...
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
identification numbers of all drug master files and other applications under this part that are referenced in the application; and the drug product's proposed indications for use. (2) A statement whether the submission is an original submission, a 505(b)(2) application, a resubmission, or a supplement to an
A chemotherapy regimen is a regimen for chemotherapy, defining the drugs to be used, their dosage, the frequency and duration of treatments, and other considerations. In modern oncology , many regimens combine several chemotherapy drugs in combination chemotherapy .
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to ...
A kardex (plural kardexes) is a genericised trademark for a medication administration record. [2] The term is common in Ireland and the United Kingdom.In the Philippines, the term is used to refer the old census charts of the charge nurse usually used during endorsement, in which index cards are used, but has been gradually been replaced by modern health data systems and pre-printed charts and ...
(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's chemotherapy-free combination treatment for a type of non-small cell lung cancer, setting up a challenge ...