J. Molner

The US Food and Drug Administration (FDA) has issued a draft guidance that proposes a uniform system for classifying protocol deviations in clinical studies. Examples of minor deviations include submitting a signed consent form with a page missing a participant’s initial and failing to conduct study procedures designed to assess participant safety. The FDA set 28 February 2025 as a deadline for comment. For more information, visit ➡️ https://lnkd.in/eZaUUG_M #regulatorycompliance

Did you know Estonia has consistently ranked 1st on the International Tax Competitiveness Index, including in 2024? Our latest blog describes the features of the Estonian tax system that set it apart, making this Baltic nation an ideal destination for building businesses ➡️ Read the article: https://lnkd.in/gZxjiaR6 #workinestonia #startupestonia #estonia

Skinny labels, which carve out patent-protected indications from generics, have generated nearly $15 billion in Medicare savings from 2015 to 2020. Recently, the US Senate received a bipartisan bill that would amend federal patent infringement law so that generic drug manufacturers can continue to submit skinny labels for generic drugs and biosimilars. #skinnylabel #Medicare

A recent report by GlobalData reviewed the state of drug shortages in Austria, Belgium, Italy, Norway, Slovenia, Spain, and Portugal. According to this research, 7,250 packs are reporting shortages, accounting for 1,278 active ingredients. Portugal reported the greatest percentages of shortages affecting more than one brand of the same active ingredient (50%), followed by Italy (44%) and Slovenia (29%). Source: https://lnkd.in/dpkBddXt

☃❄🎄Our team celebration was last week and was full of fun, friendship, and food. May this holiday season be full of magical memories for you too!

Recently, the FDA announced eight research areas that it will prioritize in 2025. These areas encompass challenges that the generic industry and the FDA’s generic drug program identify as significant. These 8 areas also offer opportunities for scientific advances to make the development of generic drugs more efficient and globally harmonized. Read the full document ➡️ https://lnkd.in/dSW4pUNu

Last week, the US Food and Drug Administration (FDA) published a draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways. The FDA recommended that sponsors talk to regulators early in their drug development. ➡️ Learn more: https://lnkd.in/e52PyrBU #drugdevelopment #ANDA #FDA

🌟This week's employee spotlight is Senior Research Scientist Jelena Jurjeva. With her vast knowledge and research discipline, Jelena is one of our key team members. We're lucky to have you Jelena! 💙 #employeespotlight #analyticalchemistry

Last week, the US Food and Drug Administration (FDA) published a draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways. The FDA recommended that sponsors talk to regulators early in their drug development. Learn more: https://lnkd.in/e52PyrBU #regulatorycompliance #pharmaceutical

🌟 We continue our Employee Spotlight series by featuring Shreyashee Majumder, a Research Scientist at J. Molner. With her dedication to scientific exploration and natural curiosity, she helps us turn research questions into effective pharmaceutical solutions, making her an invaluable asset to our team. ⬇️ Learn more about her below! #EmployeeSpotlight #ResearchScientist #Innovation #WorkInEstonia