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23 results for: regulation-pharma
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European Commission proposes new rules on blood, tissues, and cells
By Marco de Morpurgo Nicola Landolfi
Today, the European Commission adopted a proposal for a new Regulation on standards of quality and safety for substances of human origin...
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FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility
By Bethany Hills Hilary Hoffman
After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
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Patent term extensions and infringement proceedings in Australia, and the standing of an exclusive licensee
By Nicholas Tyacke Alexandra de Zwart Sarah McKenzie
For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
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MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases
By Taryn Jones Teresa Hitchcock
The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
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The moral imperative: Balancing innovation, regulation and prescription drug availability
By Jim Greenwood Geoffrey Levitt
We stand today on the threshold of almost unimaginable progress in defeating diseases that have ravaged humans for millennia. New...
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Patent term extensions in Australia – further challenges for pharmaceutical patentees
By Nicholas Tyacke Alexandra de Zwart Sarah McKenzie
Patent term extensions (PTEs) in Australia have been a hot topic over the past year.  On Friday, things got a lot hotter for patentees...
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Medicine promotion in Italy: Medicines Agency confirms increased 7% contribution due by 30 April 2022
By Nicola Landolfi
In a note published on 2 March 2022, the Italian Medicines Agency (AIFA) confirmed that all pharmaceutical companies must, by no later...
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Incentivizing diverse representation in clinical trials: At the Intersection of Science and Law Podcast Series
By Kirsten Axelsen Sarah Schick
Diverse representation in clinical trials is critical in achieving greater equity and better healthcare outcomes. In this episode, DLA...
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An analysis of the effect of drug pricing provisions in the Build Back Better Act on pharmaceutical innovation
By Kirsten Axelsen
Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
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Safety assessment of clinical trials in the EU: how will Member States be involved?
By Mariana Ricardo
The 31st January marked the day both the EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”), and the framework for the...
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New EU Clinical Trial Regulation to take effect from today
By Marco de Morpurgo Carlotta Busani
Today, the new EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”) becomes applicable. The CTR introduces a unified...
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Initiative launched to accelerate EU clinical trials (ACT EU)
By Lyndsey Hudson
Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical...
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Update: DLA Piper Global COVID-19 Vaccine Guide for Employers
By Marco de Morpurgo
DLA Piper’s Life Sciences team has updated our recent vaccine guide for employers. The changes include significant updates to several...
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Legislative initiative on off-label prescription
By Vadim Barbu
Off-label use of medication is currently not regulated in Romania. Rather, it is up to the doctors to decide on the off-label use of a...
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Portugal establishes new rules on the revision of the prices for medicinal products
By Mariana Ricardo
Ordinance no. 280/2021, dated 3 December (entering into force on December 4, 2021) creates an exceptional criterion to be used in the...
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Patent term extensions in Australia – What if the patent covers more than one approved product?
By Nicholas Tyacke Alexandra de Zwart
In its second significant recent decision addressing patent term extensions (PTEs) in Australia, the Federal Court of Australia, in Merck...
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