Feb 06, 2023 Poland - Life Sciences Monthly Brief, January 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Pharmacies; Clinical...
Dec 19, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
Dec 08, 2022 Poland - Life Sciences Monthly Brief, November 2022 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in...
Dec 01, 2022 FDA publishes draft guidance on active ingredient sameness in proposed generic drugs and their reference listed drugs By Christine Lentz The FDA recently published “Sameness Evaluations in an ANDA – Active Ingredients,” a new draft guidance detailing recommendations for...
Oct 28, 2022 Considering Modifications to Existing FDA Regulatory Incentives to Achieve Greater Racial and Ethnic Diversity in Clinical Trials for Drug Approvals By Kirsten Axelsen When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...
Oct 20, 2022 The potential for unintended consequences in the Inflation Reduction Act By Jim Greenwood Alex Pinson Jamie Gregorian The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...
Oct 19, 2022 EU Pharma & Medical Device Regulation 2023 By Marco de Morpurgo Nicola Landolfi Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
Oct 12, 2022 The latest legislative changes in the pharmaceutical industry in Poland By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Urszula Grębowska In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.
Oct 06, 2022 New IFPMA/EFPIA guidance on social media and digital channels By Marco de Morpurgo Carlotta Busani The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
Sep 23, 2022 Interchangeability of biosimilar medicines confirmed by EMA and HMA By Mariana Ricardo The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement on the interchangeability of...
Jul 14, 2022 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...
Jun 27, 2022 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...
May 17, 2022 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...
Apr 04, 2022 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...
Mar 30, 2022 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...
Mar 28, 2022 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...