News & Analysis as of

Comment Period Regulatory Oversight European Union

A&O Shearman

SRB consultation on operational guidance on resolvability testing for banks

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The Single Resolution Board (SRB) has opened a consultation on its operational guidance on resolvability testing for banks under the SRB's remit. It aims to ensure that European banks are regularly testing their capabilities...more

A&O Shearman

UK Conduct Regulator Consults on Guidance on Managing Inside Information

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The U.K. Financial Conduct Authority has published a newsletter for primary market participants seeking feedback on draft best practice guidance for government departments, industry regulators and public bodies on the...more

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l July 2019 #3

LEGISLATION, REGULATIONS & STANDARDS - AGs Submit Comment to FDA on Cannabis - A group of 38 state attorneys general have submitted a letter to the U.S. Food and Drug Administration (FDA) in response to the agency’s...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l April 2019

FDA Announces Next Steps in Cannabis Regulation - The U.S. Food and Drug Administration (FDA) has announced that it will take a number of steps to advance its consideration for the potential regulatory framework for...more

Hogan Lovells

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

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On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

Holland & Knight LLP on

Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Hogan Lovells on

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Hogan Lovells

Corporate Insurance Newsletter – August 2018

Hogan Lovells on

The Hogan Lovells’ Corporate Insurance Newsletter for August has been published. This provides a round-up of UK, EU and international regulatory developments relevant to UK based insurance market participants. ...more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

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The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Hogan Lovells

The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public...

Hogan Lovells on

On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for...more

Hogan Lovells

UK - Insurance Distribution Directive: Proposal to extend application date

Hogan Lovells on

The Insurance Distribution Directive ((EU) 2016/97, the “IDD”) came into force on 22 February 2016, and the current deadline for transposition by member states is 23 February 2018. The impact of the IDD has been previously...more

Hogan Lovells

EMA envisage to link development of companion diagnostics and personalised medicines

Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface...more

Latham & Watkins LLP

Policing the Robots — Robo-Advice Under MiFID II

Latham & Watkins LLP on

Do robots give suitable advice? ESMA proposes updates to suitability guidelines to address robo-advice. Given the technological evolution of the advice market, firms offering a robo-advice service are faced with a...more

A&O Shearman

European Securities and Markets Authority Seeks Views on Distributed Ledger Technology

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The European Securities and Markets Authority published a discussion paper on how distributed ledger technology (including, for example, "blockchains") applies to the securities markets. ESMA is assessing the risks posed by...more

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