Application Drug Investigational New Software Write' title='Application Drug Investigational New Software Write' />Guidance Document Product Monograph.Contact Bureau of Policy, Science and International Programs.Adopted Date 2.Revised Date 2. 01.Effective Date 2.Forword.Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations.Application Drug Investigational New Software Write' title='Application Drug Investigational New Software Write' />August 31, 2017 Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda.They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach.Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification.Robin Feldman on Drug Patents, Generics, and Drug Wars EconTalk Episode with Robin Feldman.Home Page for the Food and Drug Administration FDA.Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product.Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.Domunent Revision History.Version.Document Name.Change Made.Dates.Guidance for Industry Product Monograph Initial Issuance of Guidance and Templates Adopted Date.Effective Date 2.Guidance Document Product Monograph Overdosage section.Addition of standard boxed messageeporting Suspected Side Effects.Administrative updates Effective Date.Guidance Document Product Monograph Part III Patient Medication Information PMIPart III, formerly titled Consumer Information was revised to include plain language elements, including new language and formatting Adopted Date 2.Effective Date 2.Guidance Document Product Monograph Part I Health Professional Information Part II Scientific Information Appendices A, B, C, DAll 5 associated templates These sections were revised with plain language enhancements including reorganization of information Adopted Date 2.Revised Date 2.Effective Date 2.Table of Contents.Introduction. 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Purpose The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content.The product monograph is an integral part of New Drug, Supplement to a New Drug, Abbreviated New Drug and Supplement to an Abbreviated New Drug Submissions.A product monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be compared.What Is a Product Monograph A product monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug.A product monograph should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions andor clinical pharmacology, and its indications.The product monograph should also include contraindications, dosage and administration, symptoms and treatment of overdosage, dosage forms, warnings, precautions, adverse reactions, drug interactions, effects on laboratory tests, storage and stability, special handling instructions, pharmaceutical information, information on clinical trials, microbiology, toxicology, and information for the patient.In addition, the product monograph should state both the dates of initial approval and revision.Medical and Scientific Implications.From a medical and scientific standpoint, the prime objective of a product monograph is to provide essential information that may be required for the safe and effective use of a new drug.As far as the health professional is concerned, the information provided should be as meaningful and helpful as possible.However, only those indications and clinical uses that are based on substantial evidence of efficacy and safety and that are the subject of a New Drug Submission, or an Abbreviated New Drug Submission, or a Supplement to either submission that has received a Notice of Compliance pursuant to Section C.Food and Drug Regulations, should be included in the product monograph.The product monograph is not intended to serve as a repository of all information currently available on a drug.Windows Xp Dark Lite 2012 Presidential Election '>Windows Xp Dark Lite 2012 Presidential Election .The product monograph is based primarily on data submitted by a sponsor and evaluated by Health Canada as part of the regulatory drug review and authorization process.As a result, it may not reflect the entire existing body of evidence.Regulatory Implications.Product Monograph.The product monograph, as a document, will be included by Health Canada as part of the Notice of Compliance respecting a New Drug Submission or, when appropriate, a Supplement to a New Drug Submission, an Abbreviated New Drug or a Supplement to an Abbreviated New Drug Submission.The product monograph serves as a standard against which all promotional material, or advertising distributed or endorsed by the sponsor about the drug can be compared.The product monograph serves the following purposes It contains all the representations to be made in respect of the new drug as required by paragraph C.C.Food and Drug Regulations.It fulfils the requirements for adequate directions for use for new drugs included in a number of Sections having to do with labelling in Parts C and G of the Food and Drug Regulations.It identifies the information that is to be provided on request when a package insert is not included with a new drug product and a health professional requests information relevant to clinical use.It identifies the information that should be provided to the patient respecting the use of that product that is i.Part III, Patient Medication Information.It establishes the limitations parameters for all advertising, representations, and promotional or information material distributed or otherwise endorsed by the sponsor.Subsection C.Food and Drug Regulations prohibits the advertising of a new drug for any use of the drug or for any claim that has not been the subject of a cleared submission.As this information is represented in the product monograph, no professional or published literature should be quoted, distributed, or otherwise provided by the sponsor if it refers to claims or indications for use that are not supported by the current product monograph.Prescribing Information.The information described in Part I Health Professional Information of the product monograph contains prescribing information, and serves the following purposes It identifies the information to be provided if a package insert is included with a new drug product.It identifies information to be provided as part of all professional material and that may be used for promotional and advertising purposes, other than in the case of reminder notices.In addition to Part I, the information described in Part III Patient Medication Information may also be provided as part of the package insert for a new drug product.Patient Medication Information The information described in Part III Patient Medication Information of the product monograph contains information for the patient.This portion of the product monograph identifies the information that is to be provided to the patient or consumer either at the time of dispensing as a separate document, or as a package leaflet.When is a Product Monograph Required A draft copy of the proposed or revised product monograph should be included in the master volume when a New Drug, Supplement to a New Drug, Abbreviated New Drug or Supplement to an Abbreviated New Drug Submission is filed for either a prescription or nonprescription drug.Health Canada will advise the sponsor if the New Drug Submission or Supplement to a New Drug Submission is judged to be incomplete in complying with the requirements of Section C.C.
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