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Jan 6, 2016



FDA issues new Draft Guidance on Communication between Sponsors and FDA
Best Practices for Communication Between IND Sponsors and FDA During Drug Development-Guidance for Industry and Review Staff

The purpose of this guidance is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This guidance describes:

  • FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity
  • The scope of appropriate interactions between the review team and the sponsor
  • The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program
  • General expectations for the timing of FDA response to IND sponsor inquiries
  • Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development
  • Expectations for appropriate methods, including the frequency, of such communications

Read the pdf

New FDA Guidance on meetings with Biosimilar Companies
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants: Guidance for Industry

This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and biosimilar biological product sponsors or applicants.

The FDA has committed to meeting certain performance goals set forth in a letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives.4 The performance goals include meeting management goals for formal meetings that occur between the FDA and sponsors or applicants during the development phase of a biosimilar biological product. The FDA encourages sponsors and applicants to use the meetings described in this guidance to optimize product development and facilitate submission of marketing applications.

Read the pdf

EMA aims to reinforce compliance with good clinical practice
Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted

The European Medicines Agency (EMA) will not accept the replacement of a pivotal clinical study that has been found to be non-compliant with good clinical practice (GCP) by another study during the assessment of a centralised marketing-authorisation application. This position, outlined in a paper published today, aims to reinforce the application of GCP during the conduct of clinical trials by applicants.

GCP is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects.

According to European Union (EU) legislation, all clinical trials submitted to a regulatory authority in the EU to support a marketing-authorisation application must be conducted in compliance with GCP.

This ensures that the rights, safety and well-being of the individuals recruited for these trials are protected and that clinical trial data are credible and reliable irrespective of where in the world the trials have been carried out.

Read more online

Endpoint Adjudication Survey Results are in!
The recently launched endpoint adjudication survey results are out:

The Clinical Endpoints Independent Review & Adjudication Group and Ethical Clinical designed and executed an industry survey, which was publicized on LinkedIn and through Applied Clinical Trials, that evaluates the impact of technology utilization in clinical endpoint adjudication. The article published on Applied Clinical Trials delved into some of the data to uncover opinions about traditional endpoint adjudication use (i.e., Excel, paper, emails, etc.) compared to those who used eClinical technologies to adjudicate events. Beat Widler provided support to the review team.

Read more online


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