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Dec 3, 2014

European Guidelines on ePrescriptions
Guidelines on ePrescriptions were adopted by the European eHealth Network on 18th November 2014

Today at the 6th meeting of the eHealth Network in Brussels, chaired by Austria and co-chaired by the European Commission, guidelines on ePrescriptions for the purpose of interoperability between Member States were adopted.

National health systems are moving towards electronic systems for medical prescriptions. The Commission and EU countries have a common goal to ensure that these electronic prescriptions can be used safely in another Member State. This is why the eHealth Network, made up of all 28 EU countries and chaired by the Commission, has been working jointly on ePrescriptions.

The guidelines lay out the type of data needed to share prescriptions across borders. They also describe how the data should be transferred, provided the patient gives his or her consent to use the ePrescription service. The guidelines can be used by Member States on a voluntary basis.

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Rare Pediatric Disease Priority Review Vouchers - Guidance for Industry
FDA has published its draft guidance on rare pediatric disease priority review.

This guidance is intended to assist developers of rare pediatric disease products in assessing whether their product may be eligible for rare pediatric disease designation and a rare pediatric disease priority review voucher. It also clarifies the process for requesting such designations and vouchers, sponsor responsibilities upon approval of a rare pediatric disease product application, and the parameters for using and transferring a rare pediatric disease priority review voucher.

Regulations on vouchers are quite urgently needed, even though they give an incentive to companies developing urgently needed drugs in niche indications. But they also do raise the question of the right incentive from an ethical perspective.

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Exception From Informed Consent Requirements for Emergency Research
This is a 17 Nov 2014 update from the previous MAPP version dated 4 Feb 2003

This MAPP describes policies and procedures for consistent review and administrative oversight of an investigational new drug application (IND) for emergency research in which the clinical investigation includes a request, pursuant to 21 CFR 50.24, for an exception from the requirement to obtain informed consent from patients.

This MAPP does not apply to emergency treatment of individual patients with investigational drugs without informed consent by physicians carrying out medical care in a life-threatening situation as provided under 21 CFR 50.23 (see also the definition of emergency use at 21 CFR 56.102(d)) or to an emergency situation that does not allow time for submission of an IND as provided under 21 CFR 312.310(d) (i.e., “emergency procedures” for individual patients).

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