Nov 15, 2022 Clinical Trials and Privacy Matters: A Cross-border Guide By Marco de Morpurgo This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will...
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...
Feb 06, 2023 Clinical trials in the EU: mandatory CTIS procedures and new transparency requirements from 31 January 2023 By Marco de Morpurgo Nicola Landolfi On 31 January 2023, the new Clinical Trials Information System (CTIS) established by Regulation (EU) 536/2014 on clinical trials (CTR)...
Feb 01, 2023 Working on the affordability of medicines: 2023 begins with an important message on excessive pricing - Portugal By Mariana Ricardo Early this year, the Portuguese Minister of Health stated the public expense with medicines in 2022 showed an increase of more than EUR...
Jan 30, 2023 Swedish government proposes fines between SEK 25k - 100m (approx. EUR 2,500 – 10 million) for late backorders by pharmaceutical companies By Fredrika Allard The Swedish government has on 24 January 2023 proposed a bill with actions aimed at improving the availability of medicines. The bill...
Jan 23, 2023 Pharmaceutical and medical sector in Poland, DLA Piper Report By Andrzej Balicki, Ph.D. Jolanta Dabrowicz We would like to invite you to read our report summarising the second edition of the DLA Piper survey "Pharmaceutical and medical sector...
Jan 19, 2023 What is the projected – and much anticipated – key pillar for the health sector in Brazil in 2023? By Bruna Rocha Juliana Marcondes Victoria Cristofaro During the World Economic Forum 2023 in Davos, specialists discussing the topic of health unanimously indicated that “the past three...
Jan 18, 2023 FDORA implements new FDA requirements for foreign drug and medical device companies By Melissa Gilmore On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law, which contains the Food and Drug Omnibus...
Jan 12, 2023 Poland - Life Sciences, Monthly Brief, December 2022 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our December monthly briefing, which covers key updates and insights in the following areas: Clinical trials;...
Jan 11, 2023 New therapeutic products regulatory regime proposed for New Zealand By Emma Moran Suzanne Trounson The New Zealand government has introduced the Therapeutic Products Bill which is intended to replace the existing medicines, medical...
Jan 10, 2023 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 The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
Jan 06, 2023 Inflation Reduction Act: Discussion About the Mixed Effect on Costs for Drugs By Kirsten Axelsen The American Enterprise Institute (AEI), a public policy think tank, published a piece this week by Kirsten Axelsen on the potential cost...
Jan 03, 2023 Portugal: Revision to the industry code of ethics effective from January 1st By Mariana Ricardo APIFARMA – Portuguese Pharmaceutical Industry Association (Apifarma) recently approved a revision to the Code of Ethics for Promotion...
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...
Nov 21, 2022 Inspiring Women in the Life Sciences Industry: what we can learn from them By Lyndsey Hudson As someone who believes strongly in empowering women in the workplace and building a diverse and inclusive culture, I really enjoyed...