News & Analysis as of August 4, 2025

Pharmaceutical Industry

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

Medicines shortages under the EU pharma law package

Hogan Lovells on 7/15/2025

The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

Morris James LLP on 6/5/2025

Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

Hogan Lovells on 5/20/2025

The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

Hogan Lovells on 3/27/2025

On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

Regulation of COVID-19 Tests in the EU: when do you need to involve a Notified Body?

Hogan Lovells on 10/22/2020

Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19 outbreak and a number of companies...more

What's New in Washington - September 2020

Akin Gump Strauss Hauer & Feld LLP on 9/15/2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures

Hogan Lovells on 3/18/2020

On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more

AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency

Hogan Lovells on 3/16/2020

Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

Robins Kaplan LLP on 3/3/2020

Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

Hogan Lovells on 2/14/2019

With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

Hogan Lovells on 5/29/2018

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

SCENIHR Identifies Use of Nanomaterials for Medical Imaging and Drug Delivery and Graphene Nanomaterials as Emerging Issues

Bergeson & Campbell, P.C. on 4/13/2015

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the...more

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European Union › Public Health › Pharmaceutical Industry

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