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Belgium
Arnold & Porter
On 13 December 2019, the European Medicines Agency ("EMA") published a Questions and Answers document ("Q&A")
Hogan Lovells
Oatly, Inc. has chosen to discontinue its "no added sugars" advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD)
Hogan Lovells
FDA recently released a Draft Guidance for Industry entitled, "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting" ("Draft Guidance"). The Draft Guidance
Hogan Lovells
On June 18, the Food and Drug Administration (FDA) issued its final guidance document on added sugars labeling for honey, maple syrup, and other single-ingredient sugars and syrups; and certain cranberry products.
Hogan Lovells
On Thursday, FDA published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application" that contains minor revisions ...
Hogan Lovells
On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection
Dentons
Following the change of mind that is taking place in many jurisdictions around the world, Belgium is gradually taking steps relating to the production and research into cannabis products for medicinal purposes.
Van Bael & Bellis
Convinced that these practices infringed its copyright in the taste of "Heksenkaas", Levola brought an action against Smilde for copyright infringement.
Hogan Lovells
The default legal position is that the UK will leave the EU automatically at 11pm on 29 March 2019 with no "deal" in place, unless something else is agreed.
Hogan Lovells
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars.
Hogan Lovells
Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs).
Hogan Lovells
On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the Administration's plan to reduce drug prices.
European Union
Hogan Lovells
The European Medicines Agency (EMA) has committed early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.
Mayer Brown
On December 5, 2018, the General Court (Court) ruled in favor of the European Commission in a case brought by Bristol-Myers Squibb Pharma (BMS) ...
Van Bael & Bellis
In reaching this conclusion, the Court referred to the Belgian regulatory framework which embraces the principle of "therapeutic freedom" which, as a rule, prohibits substitution in the deliverance of medicines.
Nctm Studio Legale
This article is based on a presentation made to the Montreal/Statale University 2018 Summer School in bilateral trade relations between the EU and North America, given on 28 May in Montreal Canada.
Van Bael & Bellis
Under Article 4 of the Directive, a person injured by a defective product should prove the damage, the defect and the causal relationship between defect and damage.
Van Bael & Bellis
On 27 April 2017, the President of the Dutch-language Commercial Court of Brussels decided a case concerning the repackaging of parallel imported pharmaceuticals, in which it applied the so-called...
Van Bael & Bellis
Subject to a few exceptions, EU Member States should apply the national implementing measures of the TPD as from 20 May 2016.
Hogan Lovells
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs
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