Searching Content from Belgium indexed under Food, Drugs, Healthcare, Life Sciences ordered by Published Date Descending.
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FDA Publishes Final Guidance On ANDA/505(B)(2) NDA Pathways
On Thursday, FDA published the final guidance document, "Determining Whether to Submit an ANDA or a 505(b)(2) Application" that contains minor revisions ...
28 May 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FDA Addresses Industry Feedback On Routine Inspections By Formalizing Processes And Standards In A Draft Guidance
On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection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
Recent Developments In Belgium Regarding Production And Research Into Cannabis Products
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.
9 Apr 2019
Taste Of Food Product Does Not Qualify For Copyright Protection
Convinced that these practices infringed its copyright in the taste of "Heksenkaas", Levola brought an action against Smilde for copyright infringement.
25 Feb 2019
Brexit Snapshot: Food & Beverage
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.
20 Feb 2019
Trump Administration Proposes Ambitious AKS Rewrite On Drug Rebates, But Needs Answers To Big Questions
In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs
14 Feb 2019
European Union
13 Dec 2018
Regulatory Insights For Life Sciences And Health Care Investments: Drug Pricing And Reimbursement
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.
4 Dec 2018
Parallel Trade: Rebranding Of Generic Medicine To Originator Brand Name Constitutes Trade Mark Infringement
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.
European Union
31 Aug 2018
Is The EU Becoming More Unilateralist?
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.
European Union
29 Aug 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
Court Of Justice Of European Union Lowers Evidence Standard In Vaccine-Liability Case
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.
European Union
11 Aug 2017
Brussels Commercial Court: Parallel Imported Pharmaceuticals Must Comply With Latest Packaging
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...
European Union
16 Jun 2017
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
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