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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 Technology Policy, Michael Kratsios, jointly issued a memorandum on “FY 2020 Administration Research and Development Budget Priorities.” This is an annual document, providing overall policy guidance to the federal agencies as they prepare their budget submissions for the next fiscal year. The guidance does not include any specific funding targets,…
In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The documents which are available on the European Commission website include the following practical guides: Factsheet for manufacturers of medical devices The factsheet is intended to provide a general overview of the consequences of the MDR on…
The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced therapy medicinal products (“ATMPs”). The purpose of the Guidelines is to adapt existing good clinical practice rules (“GCPs”) to ATMPs. This step is required by Article 4 of Regulation 1394/2007 on ATMP, which provides that the European Commission to draw up guidelines…
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 competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April 2016 draft guidance that Dr. Gottlieb said aims to help biosimilar manufacturers prepare labeling submissions in a manner that would…
In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common rulebook” between the parties in relation to goods. The White Paper discusses what is foreseen as the future relationship between the parties in some detail.…
The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. If the draft Withdrawal Agreement is finalised by the UK and EU, during the implementation period the UK will no longer be an EU Member State but the UK and EU will continue to access each other’s market on broadly the same terms as at…
Both Chambers of Congress are considering legislation that would amend the Telephone Consumer Protection Act (“TCPA”).  Introduced in the House by Congressman Pallone (H.R. 6026) and in the Senate (S. 3078) by Senator Markey, the Stopping Bad Robocalls Act adds a new definition, “robocall,” in place of “automated telephone dialing system.”  The new term would include devices that make calls using “numbers stored on a list” (in addition to dialing random or sequential numbers).  The…
On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and all EU Member States to have an urgent discussion concerning the timelines for the application of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). In the four pages position paper, MedTech Europe underlines that the industry has significant concerns…
The U.S. Small Business Administration (SBA) Office of Hearings & Appeals (OHA) recently held that an entity may be affiliated with another entity solely because it holds a very small minority ownership interest (less than 1%) in that entity. OHA’s ruling is noteworthy because under the SBA’s rules, the employees or revenue (depending on the NAICS code) of a concern and its “affiliates” must be aggregated when determining a small business concern’s size and eligibility…
On 19 July, the UN working group tasked with elaborating an international, legally binding instrument on business and human rights published the text of a draft treaty (see the draft here and the accompanying statement by the Chair of the Working Group, here). In this blog, we look at its key terms and what it might mean in practice for transnational businesses. Drafting history In October 2017, following the last round of deliberations, we…