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Belgium
Arnold & Porter
On 7 April 2020, the European Medicines Agency (EMA) issued a Notice to sponsors on validation and qualification of computerised systems used in clinical trials (Notice).
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FDA recently released a Draft Guidance for Industry entitled, "Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting" ("Draft Guidance"). The Draft Guidance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
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual)
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
The Minister of Health, Dr Aaron Motsoaledi (Minister), has been entrusted with the unenviable task of overseeing South Africa's transition to universal health coverage
Hogan Lovells
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products.
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On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection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.
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).
European Union
Hogan Lovells
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.
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.
Hogan Lovells
Shortly after updating the related draft Questions and Answers document, the European Commission has published two new...
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) ...
Worldwide
Hogan Lovells
Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients.
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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