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Article
Advanced Therapy For Melanoma Receives Positive Opinion
On October 23, 2015, the CHMP recommended authorizing Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be removed by surgery...
European UnionFood, Drugs, Healthcare, Life Sciences
Jones Day
Article
Aflibercept Biosimilar Updates In Europe
On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz's aflibercept biosimilar AFQLIR.
European UnionFood, Drugs, Healthcare, Life Sciences
Goodwin Procter LLP

Commission Addresses Importing Organic Products From Korea Into The EU

The European Commission on January 23, 2015 issued Commission Implementing Regulation (EU) 2015/131, which amends Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007...

European UnionFood, Drugs, Healthcare, Life Sciences

Council Of European Union Appoints New EFSA Management Board Member

The Council of the European Union has appointed Michael Winter to the Management Board of EFSA.

European UnionFood, Drugs, Healthcare, Life Sciences

EC Invites Industry To Develop Self-Regulatory Rules For The Labeling Of Alcoholic Beverages

On March 13, 2017, the EC adopted a report concerning the mandatory labeling of the list of ingredients and the nutrition declaration for all alcoholic beverages.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA's Scientific Opinion On GM Oilseed Rape Open For Comment

In accordance with Regulation (EC) No 1829/2003 concerning GM food and feed, the public has a month to make any comments on the opinion.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Consults On Draft TCC Report

EFSA and the World Health Organization have published the draft conclusions and recommendations of their joint workshop on the Threshold of Toxicological Concern approach.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Develops New Risk Toolbox

EFSA's experts have developed a toolbox for risk ranking for prioritization of food and feed-related issues, on the basis of the size of anticipated health impact.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Launches Consultation On Caffeine Assessment

EFSA announced it is seeking comments and feedback on a draft assessment finding that single doses of caffeine up to 200 mg and daily intakes of up to 400 mg do not raise safety concerns for adults in Europe.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Launches Public Consultation Into "Cocktail Effects" Of Chemicals

Interested parties are invited to submit written comments by November 30, 2016.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Launches Public Consultation On Dietary Reference Values For Potassium

The document proposes dietary reference values for adults, children and infants, and pregnant and lactating women.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Launches Public Consultation On Health Claims Related To Gut And Immune Function

On February 9, 2015, EFSA launched a public consultation giving stakeholders and other interested parties the opportunity to comment on the draft update of its guidance for health claims related to gut and immune function.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Opens Magnesium Consultation

The draft opinion proposes adequate intakes based on observed intakes in healthy populations in the EU.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Publishes Scientific Opinions On Six Health Claims

On May 13, 2015, the European Food Safety Authority published its scientific opinion on six new health claims.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA Simplifies Procedure For Exchange Of Pesticide Active Substance Documents

Starting on February 24, 2015, the European Food Safety Agency's ("EFSA") online platform for sharing Draft Assessment Reports, Renewal Assessment Reports, and sanitization of background documents...

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA To Present Draft GM Plant Allergenicity Guidance To Stakeholders

On November 23, 2016, EFSA will present its draft guidance document on allergenicity of genetically modified ("GM") plants at a meeting in Parma, Italy.

European UnionFood, Drugs, Healthcare, Life Sciences

EFSA To Reopen Opinion On Perchlorate In Fruits And Vegetables

On January 23, 2015, EFSA announced it would reexamine its 2014 scientific opinion on perchlorate in food following confirmation there was a technical error in the estimation of consumer exposure to perchlorate in the diet.

European UnionFood, Drugs, Healthcare, Life Sciences

EMA Call For Civil Society Members For Two Committees

Expressions of interest are due September 30, 2015.

European UnionFood, Drugs, Healthcare, Life Sciences

EMA Calls For Public Consultation On Clinical Trial Protocol

The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014).

European UnionFood, Drugs, Healthcare, Life Sciences

EMA Consults On Draft Guideline On Development Of Fixed Combination Products

On May 13, 2015, the European Medicines Agency ("EMA") published its draft guidelines on clinical development of fixed combination medicinal products.

European UnionFood, Drugs, Healthcare, Life Sciences

Showing 1–20 of 14464 results

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