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Focus on Regulation Blog

Articles: 1-10 of 320

Selective Distribution & Online Sales: Higher Regional Court of Frankfurt confirms CJEU findings and provides further guidance

Germany - September 11 2018 After the Court of Justice of the European Union (CJEU) had issued its landmark judgment in the Coty case1 on reference for preliminary ruling, the…

Eighth Circuit Finds that Bare “Technical Violations” of the TCPA Do Not Establish Standing

USA - September 6 2018 In St. Louis Heart Center v. Nomax, Inc., the Eighth Circuit held that an “alleged failure to provide a technically compliant opt-out notice” in a fax…

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

USA - September 5 2018 Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug…

U.S. Senate passes bill requiring prescription drug ads to include prices

USA - August 28 2018 On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor…

UK Government publishes first no-deal Brexit notices for food

European Union, United Kingdom - August 24 2018 The Government has released its first batch of technical notices which aim to prepare UK citizens and businesses for an exit from the EU without a…

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…