Regulatory Standards, New Guidance, Life Sciences

FDA Announces Plan to Phase Out Animal Testing Requirement

Holland & Knight LLP on 4/15/2025

The U.S. Food and Drug Administration (FDA) on April 10, 2025, announced a significant policy shift aimed at reducing its reliance on animal testing for drug development and incorporating new approach methodologies (NAMs)...more

Draft text of new Spanish regulation on medical devices is opened for contributions

Hogan Lovells on 6/15/2021

The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021. The direct application of...more

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on 12/8/2020

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

FDA Gives Guidance on Reporting Medical Device Shortages

Faegre Drinker Biddle & Reath LLP on 5/17/2020

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or...more

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

Hogan Lovells on 1/25/2019

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

Hogan Lovells on 1/8/2019

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

Hogan Lovells on 11/26/2018

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

Hogan Lovells on 10/22/2018

The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more

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