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Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Pharmacies; Clinical...
Cortex - Life Sciences Insights
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regulation-pharma
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The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
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We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in...
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The FDA recently published “Sameness Evaluations in an ANDA – Active Ingredients,” a new draft guidance detailing recommendations for...
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When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...
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The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...
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Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.
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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement on the interchangeability of...
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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...