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Dec 3, 2018

FDA changes Informed Consent Rules
FDA takes steps to allow greater flexibility for clinical investigators about informed consent in minimal risk situations

Basically, FDA regulations (21CFR Parts 50 and 56) allow exceptions from the general requirements of informed consent in life-threatening situations or for emergency research. Current FDA regulations do not allow an exception from the general requirements of informed consent for minimal risk clinical investigations. This proposed rule would add such an exception by adding a new section, 50.22. In contrast, the Common Rule does include a waiver of informed consent provisions for minimal risk research. While FDA amended its regulations in parts 50 and 56 to partially match the Common Rule some time ago, the Agency did not match the provision for waiver or alteration of informed consent for minimal risk research. Here is a link to the actual FR page.

Here is a verbatim “cut and paste” of the announcement: “In today’s edition of the Federal Register, the Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking entitled "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations." FDA is proposing to amend its regulations to implement section 3024 of the 21st Century Cures Act. This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.” By “today’s edition”, the announcement is referring to 15 November 2018. Also, the FDA will withdraw its 2017 guidance if this rule is finalized. Here is a link to the current guidance from July 2017.

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FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018

To enhance the use of surrogate endpoints (SEs) in drug development, expand existing transparency initiatives, and facilitate the development of new and innovative products for patients, the FDA has made available additional resources for drug development programs intending to use SEs. One such resource is the Table of Surrogate Endpoints (SEs) That Were the Basis of Drug Approval or Licensure for both traditional and accelerated approval. This table lists SEs the FDA has accepted or could accept as primary efficacy endpoints in drug development programs. In addition, the FDA is also accepting Type C IND meeting requests focused on potential novel SEs that may be used in drug development programs.

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EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries

This discussion paper has been prepared by the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative. The main objective of this initiative is to facilitate use of patient registries to support regulatory decision-making.

The paper discusses methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes. It has been published to seek comments and suggestions from all the interested parties. All the responses will be considered for the finalisation of the document with the EMA Committees in Q4 2019.

Please send your comments and suggestions before 30 June 2019 by sending the Form for submission of comments or an annotated version of the document (mentioning on the first page your name, affiliation and contact details) to:

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EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials

This Qualification Opinion is intended to give information about the regulatory acceptability to use an eSource Direct Data Capture (DDC, or simply eSource in this document) in clinical trials conducted to support a Marketing Authorization Application for a medicine.

In the context of this Qualification Opinion, the general term “eSource DDC” refers to an electronic application and/or device that allows direct entry of source data, and to directly identify some of these data as CRF (Case Report Form) data, for clinical trial purposes at the point of care by investigator site staff, for example via an electronic tablet. It is not intended to identify or support a specific, proprietary system, but to discuss some of the characteristics a system for direct data entry should present. It should also be noted that guidance on Electronic Systems is currently under development at EMA, and once into force it would constitute the definitive guidance.

Read the pdf

China makes switch to faster approval system for imported drugs
NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries

This regulation describes this specific faster pathway in terms of the applicable drug categories, the procedure of selecting drugs, the review and approval procedures, and related requirements. Estimated three months and six months for orphan drugs and other new drugs that have been on the US, EU, or Japan markets in the recent ten years to get the approval respectively. The regulation also states submission requirements, such as supportive documents, CTD filling requirements, ethnic sensitivity analysis reports, post-marketing study and the risk management activities, and the declaration of the consistency of dossier.

Issued by NMPA & NHC, REF[2018] No.79


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