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Hogan Lovells

Médicaments hybrides et inscription au répertoire des groupes génériques

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Le Conseil d’Etat confirme que seule la décision d’autorisation de mise sur le marché peut définir un médicament en tant que générique. Par deux décisions récentes du 7 juillet 2021 (Johnson & Johnson, req. n° 437803 et...more

Hogan Lovells

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

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The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic. In two recent decisions of 7 July 2021 (Johnson & Johnson, req. no....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 2021

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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

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The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

Hogan Lovells

Poland: impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for...

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The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques....more

Hogan Lovells

Brexit: the impact on supplementary protection certificates (SPCs)

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On 6 February 2019 the House of Commons and House of Lords approved The Patents (Amendment) (EU Exit) Regulations 2018 (Patent SI), which, if it is signed into law, will come into force on Brexit day (i.e. 29 March 2019 or...more

Hogan Lovells

New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

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On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. ...more

Manatt, Phelps & Phillips, LLP

Agreement Reached on Bipartisan Federal GMO Food Labeling Bill

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Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws - Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

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As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

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