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23 results for: regulation-pharma
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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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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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For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
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The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
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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 (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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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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Diverse representation in clinical trials is critical in achieving greater equity and better healthcare outcomes. In this episode, DLA...
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Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
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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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Today, the new EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”) becomes applicable. The CTR introduces a unified...
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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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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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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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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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In its second significant recent decision addressing patent term extensions (PTEs) in Australia, the Federal Court of Australia, in Merck...