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Focus on Regulation Blog

Articles: 1-10 of 315

MDR and IVDR: the European Commission published some guidance documents

European Union - August 13 2018 In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the…

The Trump Administration Issues Its R&D Budget Priorities for FY 2020

USA - August 13 2018 On July 31, the Director of the Office of Management and Budget, Mick Mulvaney, and the Deputy Assistant to the President, Office of Science and…

New EU draft guidelines on clinical trials with ATMPs open for consultation

European Union - August 10 2018 The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft…

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

USA - August 9 2018 On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to…

Brexit, medical devices and transfer of notified bodies. What will be the procedure?

European Union, United Kingdom - August 7 2018 In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common…

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

European Union, United Kingdom - August 6 2018 The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30…

SBA Update: Less Than 1% Minority Shareholder Interest Could Impact Eligibility for Small Business Contract Awards

USA - July 26 2018 The U.S. Small Business Administration (SBA) Office of Hearings & Appeals (OHA) recently held that an entity may be affiliated with another entity…

UN treaty on business and human rights: Working Group publishes draft instrument

Global - July 26 2018 On 19 July, the UN working group tasked with elaborating an international, legally binding instrument on business and human rights published the text…

FDA proposes new ways for prescription drugs to become available over-the-counter

USA - July 19 2018 On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug…

Access to documents held by EMA: access requests by non-EU applicants to cease

European Union, United Kingdom - July 18 2018 The EMA has announced that, from 15 June 2018. The Agency will cease to accept requests for access to documents by non-EU applicants. The EMA…