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Trump touts “historic” plan to overhaul Medicare payments, create International Pricing Index

President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing...

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Boost for digital health in Germany – restrictions on remote treatment could be overturned in May 2018

At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be...

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FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited...

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FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative...

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EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation....

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Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published.

The workshop discussed the views of ...

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Excessive pricing in pharmaceutical products attracts the European Commission’s attention

In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last...

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European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of...

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EMA's initiative of expanding the use of early background summaries

In an effort to help assessors evaluate initial marketing authorization applications, the European Medicines Agency (EMA) has taken the initiative to extend the use of “early...

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The MHRA issues new guidance concerning own brand labelling or "virtual manufacturing"

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical ...

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The EU Court of Justice dismisses EMA’s appeals in interim measures and suspends the release of clinical study report to third parties

On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report...

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The MHRA issues new guidance concerning common issues in clinical trial applications

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the...

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