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Focus on Regulation Blog

Articles: 1-10 of 254

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

USA - February 14 2018 The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws…

European Commission Publishes Guidance on Brexit and UK Food Exports

European Union, United Kingdom - February 6 2018 On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission…

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

USA - January 26 2018 FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall…

FCC Avoids Shutdown For Now, But Continued Threat Looms Over TMT Sector

USA - January 23 2018 The federal government is open. But less than three weeks remain under the current reprieve and another shutdown seems possible. Although the Federal…

Freedom of Information Code of Practice Consultation

United Kingdom - January 23 2018 The Government is consulting (link below) on various revisions to the Code of Practice for public authorities on their obligations under the Freedom…

Canada steps up human rights oversight of companies operating abroad

Canada - January 22 2018 Last week, Canada announced the creation of the Canadian Ombudsperson for Responsible Enterprise (CORE), an independent officer who will be tasked…

Connected Vehicles in Focus at 2018 CES

USA - January 22 2018 In addition to displaying a wide array of next-generation connected vehicle technologies, the 2018 Consumer Electronics Show ("CES") hosted lively…

European Commission released GMP Guidelines for Investigational Medicinal Products

European Union - January 22 2018 On 8 December 2017, detailed EU guidelines on good manufacturing practices ("GMP") for investigational medicinal products for human use were adopted…

eCTD Format Required for all Mutual Recognition Procedure Submissions

European Union - January 19 2018 Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made…

FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)

USA - January 19 2018 The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable…