15 October 2015

ICH E6 (R2) GCP Guidelines Issued for Review

A new draft of the ICH GCP guideline has been modified to address the following:

  • data integrity
  • electronic records and controls
  • validation of computer systems used for GCP
  • risk management approach on behalf of the sponsor and the CRO to evaluate, identify, control, mitigate, and communicate the major risks
  • oversight responsibilities of the sponsor
  • integrity of the data
  • risk based monitoring
Download the new guideline here

07 August 2015

FDA Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics

The U.S. Food and Drug Administration released a final guidance on Analytical Procedures and Methods Validation for Drugs and Biologics.  The guidance document provides recommendations for submitting analytical procedures and methods validation data to support the documentation of the identify, strength, quality, purity and potency of drug substances and drug products.  The scope of the guidance document applies to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.

Read the Guidance document here

18 May 2015

FDA Draft Guidance for Adaptive Designs for Medical Device Clinical Studies

The U.S. Food and Drug Administration (FDA) issued a draft guidance today for Adaptive Designs for Medical Device Clinical Studies.  The document provides guidance on how to plan and implement adaptive designs for clinical studies that allow for prospectively planned modifications based on accumulating study data without undermining the integrity and validity of a trial.

Read the full draft guidance here

09 April 2015

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers, on Monday, 20 April 2015, from 1:00 p.m. – 2:00 p.m. EDT.

The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for regulated clinical investigations.  A copy of the guidance may be found at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Access the Webinar on Monday, 20 April 2015, from 1:00pm - 2:00pm using the following linkhttps://collaboration.fda.gov/guidancewebinars/

27 July 2014

Draft FDA Guidance for Informed Consent

The U.S. Food and Drug Administration (FDA) published a new draft guidance for informed consent this July 2014.  The guidance is intended to provide information to clinical investigators, study sponsors and institutional review boards (IRBs) about the FDA's informed consent regulations.  When finalised, this guidance will supersede FDA's previous publication, "A Guide to Informed Consent" that was issued in September 1988.