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FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer...


Hybrid products and registration in the generics register ("répertoire des groupes génériques")

The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic.


COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....


Developments in Spain on promotion of authorized medicinal products pending pricing & reimbursement

The debate in Spain on the possibility of promoting medicinal products in the period between marketing authorization and pricing & reimbursement has recently taken on a special...


FTC’s preliminary injunction win in hospital merger shows importance of deal and planning documents

On 4 August 2021, the District Court of New Jersey granted the Federal Trade Commission’s (FTC) motion for preliminary injunction, preventing Hackensack Meridian Health (HMH) and...


Revision of the EU general pharmaceuticals legislation – public consultation is now open

The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical...


FDA launches list of AI and machine learning-enabled medical devices

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S....


Consultation open: Review of the National Medicines Policy

The Department of Health (Department) has opened a public consultation on the review of the National Medicines Policy (NMP). As part of the review, the Expert Advisory Committee...


MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU)...

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