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Hogan Lovells Publications

With the statutory deadline approaching, FDA issues a proposed sunscreens rule Focus On Regulation

13 March 2019

On 26 February, the U.S. Food and Drug Administration (FDA) published the proposed rule, "Sunscreen Drug Products for Over-the-Counter Human Use," which describes the conditions under which ...

Hogan Lovells Publications

Would you like an extra application with that? FDA mulls requiring dual applications for combination products Focus On Regulation

08 February 2019

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...

Hogan Lovells Publications

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation

04 February 2019

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

Blog Post

South Africa's green rush- "weeding" out the confusion

01 February 2019

Following the recent landmark decision of the South African Constitutional Court, in which the private and personal use of cannabis was decriminalised, together with the publication of...

Hogan Lovells Publications

Likely FDA impact of the government shutdown: Regulatory submission reviews, inspections, and research projects Focus On Regulation

27 December 2018

Blog Post

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

31 January 2018

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of...

Blog Post

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

8 June 2017

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

Blog Post

Personalised Medicines at the top of the European Agenda Focus on Regulation

7 June 2017

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...

Blog Post

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

23 May 2017

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...

Blog Post

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

14 April 2017

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...

Blog Post

EMA's initiative of expanding the use of early background summaries Focus on Regulation

14 April 2017

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...

Blog Post

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

30 March 2017

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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