REMSadvisor.com » FDA Guidance Reports http://www.remsadvisor.com An Information Resource Site for FDA REMS Mon, 30 Jan 2012 22:59:50 +0000 http://wordpress.org/?v=2.9.1 en hourly 1 FDA Guidance for Industry: Medication Guides http://www.remsadvisor.com/fda-guidance-reports/fda-guidance-for-industry-medication-guides/ http://www.remsadvisor.com/fda-guidance-reports/fda-guidance-for-industry-medication-guides/#comments Wed, 02 Mar 2011 00:10:49 +0000 remsadvisor http://www.remsadvisor.com/?p=983 This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products:

  • When FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient.
  • When a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).

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]]> http://www.remsadvisor.com/fda-guidance-reports/fda-guidance-for-industry-medication-guides/feed/ 0 FDAAA Law Public Law 110-85 http://www.remsadvisor.com/fda-guidance-reports/full-text-of-fdaaa-law-public-law-110-85-september-27-2007-see-title-ix/ http://www.remsadvisor.com/fda-guidance-reports/full-text-of-fdaaa-law-public-law-110-85-september-27-2007-see-title-ix/#comments Fri, 22 Jan 2010 11:58:04 +0000 admin http://www.remsadvisor.com/test/?p=41 September 27, 2007

An Act: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.

[Food and Drug Administration Amendments Act of 2007]

]]> http://www.remsadvisor.com/fda-guidance-reports/full-text-of-fdaaa-law-public-law-110-85-september-27-2007-see-title-ix/feed/ 0 FDA Procedures: SOPP 8413: Postmarketing Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting http://www.remsadvisor.com/fda-guidance-reports/fda-procedures-sopp-8413-postmarketing-commitment-related-submissions-administrative-handling-review-and-cber-reporting/ http://www.remsadvisor.com/fda-guidance-reports/fda-procedures-sopp-8413-postmarketing-commitment-related-submissions-administrative-handling-review-and-cber-reporting/#comments Fri, 22 Jan 2010 11:57:32 +0000 admin http://www.remsadvisor.com/test/?p=39 The purpose of this document is to describe the procedures for administrative handling and regulatory review of postmarketing commitment (PMC) Annual Reports, Final Study Reports, and other PMC submissions to CBER for Biological License Applications (BLAs) and New Drug Applications (NDAs). This document also describes the process for reporting on the compliance of applicants with regard to PMC submissions as required by the Federal Food, Drug, and Cosmetic Act (the Act).

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]]> http://www.remsadvisor.com/fda-guidance-reports/fda-procedures-sopp-8413-postmarketing-commitment-related-submissions-administrative-handling-review-and-cber-reporting/feed/ 0 FDA Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment http://www.remsadvisor.com/fda-guidance-reports/fda-guidance-for-industry-good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment/ http://www.remsadvisor.com/fda-guidance-reports/fda-guidance-for-industry-good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment/#comments Fri, 22 Jan 2010 11:56:57 +0000 admin http://www.remsadvisor.com/test/?p=37 This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products (excluding blood and blood components). Specifically, this document provides guidance on:

  1. Safety signal identification
  2. Pharmacoepidemiologic assessment and safety signal interpretation, and
  3. Pharmacovigilance plan development.

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]]> http://www.remsadvisor.com/fda-guidance-reports/fda-guidance-for-industry-good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment/feed/ 0 FDA DRAFT Guidance for Postmarketing Studies and Clinical Trials – Implementation of 505(o) http://www.remsadvisor.com/fda-guidance-reports/fda-draft-guidance-for-postmarketing-studies-and-clinical-trials-%e2%80%93-implementation-of-505o/ http://www.remsadvisor.com/fda-guidance-reports/fda-draft-guidance-for-postmarketing-studies-and-clinical-trials-%e2%80%93-implementation-of-505o/#comments Fri, 22 Jan 2010 11:56:28 +0000 admin http://www.remsadvisor.com/test/?p=35 This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)), added by section 901 of the Food, and Drug Administration Amendments Act of 2007 (FDAAA). Section 505(o) authorizes FDA to require certain postmarketing studies and clinical trials for prescription drug and biological products approved under section 505 of the Act or section 351 of the Public Health Service Act  (the PHS Act) (42 U.S.C. 262). This guidance provides information about the requirements for postmarketing studies and clinical trials under section 505(o) of the Act. The guidance also describes the types of postmarketing studies and clinical trials that:

  • will generally be required under the new legislation (postmarketing requirements (PMRs)) and
  • will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials.

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]]> http://www.remsadvisor.com/fda-guidance-reports/fda-draft-guidance-for-postmarketing-studies-and-clinical-trials-%e2%80%93-implementation-of-505o/feed/ 0 FDA DRAFT Guidance for REMS Format and Content http://www.remsadvisor.com/fda-guidance-reports/fda-draft-guidance-for-rems-format-and-content/ http://www.remsadvisor.com/fda-guidance-reports/fda-draft-guidance-for-rems-format-and-content/#comments Fri, 22 Jan 2010 11:55:32 +0000 admin http://www.remsadvisor.com/test/?p=32 This document provides guidance to industry on:

  • The format and content of a proposed risk evaluation and mitigation strategy (REMS), including REMS supporting documentation
  • The content of assessments and proposed modifications of approved REMS
  • What identifiers to use on REMS documents
  • How to communicate with FDA about a REMS

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