Searching Content from Belgium indexed under Life Sciences, Biotechnology & Nanotechnology ordered by Published Date Descending.
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The European Commission Releases An Updated Borderline Manual For Medical Devices
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual)
3 Jul 2019
Will Government's Approach To The Adoption Of The NHI Do More Harm Than Good?
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
20 May 2019
Regulator Proposes Reducing Requirements For Radiation-Emitting Products
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.
26 Apr 2019
FDA Addresses Industry Feedback On Routine Inspections By Formalizing Processes And Standards In A Draft Guidance
On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection
17 Apr 2019
European Union
13 Dec 2018
State And Federal Food-Labeling Reforms Impose Unappreciated Complexities And Compliance Challenges
Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs).
5 Jul 2018
CMS Releases Annual Health Insurance Exchanges Final Rule
On April 9, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Benefit and Payment Parameters final rule for 2019 (2019 Payment Notice) applicable to qualified health plans (QHPs) ...
5 Jul 2018
Administration Presents Plans To Lower Drug Prices
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.
5 Jul 2018
Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)
The 2010 Physician Payments Sunshine Act created a new standard of transparency for financial relationships between pharmaceutical companies and health care professionals in the U.S.
European Union
5 Jul 2018
No Patentability For Products Of Essentially Biological Processes
Following this decision, the European Parliament asked the Commission in December 2015 to look into the patentability of these products.
European Union
13 Feb 2017
Supreme Court Acknowledges Objective Justification For Parallel Importation Of Pharmaceuticals
The Supreme Court recently handed down two judgments on the repackaging of parallel imported pharmaceuticals.
9 Feb 2017
Minister For Social Affairs And Public Health Concludes "Pact For Future" With Pharmaceutical Industry
On 27 July 2015, the Minister for Social Affairs and Public Health, Maggie De Block ("the Minister"), and the pharmaceutical sector umbrella organisations and FeBelGen entered into a "Pact for the Future"...
21 Aug 2015
ECJ Clarifies Concept Of "Human Embryo" Within Meaning Of Biotech Directive
In the facts underlying the case at hand, ISCC sought to register two UK patents relating to unfertilized human ova which have been stimulated to divide in the absence of sperm.
European Union
5 Feb 2015
Commission Fines Servier And 5 Other Generic Producers A Total Of € 427 Million Over "Pay-For-Delay" Deals And Abuse Of A Dominant Position
Perindopril is a blood pressure control medicine that used to be Servier’s bestselling medicine.
European Union
21 Aug 2014
Ambitious Reform Of The Medical Devices Regulatory Framework
The medical devices sector covers a wide range of products, from simple bandages to highly sophisticated devices such as pacemakers, as well as contact lenses, prostheses, medical equipment for hospital use, etc.
10 Jan 2013
Commission Sends Statement Of Objections To Lundbeck, Servier And Others Over "Pay-For-Delay" Agreements; Third Patent Settlement Monitoring Report Published
On 25 July 2012, the European Commission announced that it had sent a formal Statement of Objections ("SO") to Danish pharmaceutical company Lundbeck over its conclusion of so-called "pay-for-delay" agreements with four generic producers of citalopram, a antidepressant medicine.
European Union
8 Aug 2012
Commission Adopts The First-Ever International Definition Of Nanomaterials For Regulatory Purposes
The European Commission's hesitation to provide a legal definition of nanomaterials came to an end last week when its services adopted and released a long-awaited and much-debated recommendation for a regulatory definition for nanomaterials on 18 October.
European Union
30 Apr 2012
ECJ Clarifies Scope Of Supplementary Protection Certificate
On 9 February 2012, the Court of Justice of the European Union (the "ECJ") answered a preliminary question referred to it by the High Court of Justice of England and Wales (the "Referring Court") in Novartis AG ("Novartis") v. Actavis UK Ltd.
European Union
11 Apr 2012
GMOs: A Principle Established With…Precaution
In the midst of the debate over the co-existence of traditional and GM crops, the Court of Justice of the European Union (ECJ) has delivered two very important judgments in the space of a few days.
European Union
4 Oct 2011
Comitology After The Lisbon Treaty
Previous editions of EU Analyst have examined how key decisions on EU environment and life sciences regulation are taken behind closed doors. In the EU legal framework, ‘comitology’ committees (made up of a representative from each EU Member State and chaired by the European Commission) simply implement rules laid down by the Council.
14 Dec 2010
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