In a two-part video interview with Pharmaceutical Executive, Jim Shehan, Chair of Lowenstein’s FDA Regulatory practice, discusses the top legal and regulatory concerns for investors in GLP-1 drugs, emphasizing the importance of thorough research and caution in a crowded marketplace. Watch part 1: https://bit.ly/45mQWeN Watch part 2: https://bit.ly/4es9Hln #lawyers #lifesciences #regulatorycompliance #fda #pharmaindustry
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Looking to get a medicinal product approved by the UK's regulator? 💊 Check out our latest blog post on the new #MHRA International Recognition Procedure (launching on 1st Jan 2024)! 👇 👇 👇 #regulatoryaffairs #pharmaceuticals
Did you know that on January 1, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) is launching the International Recognition Procedure (IRP)? The IRP aims to facilitate the UK registration of pharmaceutical products post-Brexit. ✔️ Interested in this topic? Read our article to explore this new IRP, and learn how to navigate regulations and the IRP's two assessment routes for streamlined medicine registration in the UK. 💊 #Pharma #IRP #MedicinalProducts #MHRA #UK 👉 https://hubs.li/Q02c00gl0
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Avoid 483 Forms and exceed the FDA’s expectations by following this fortifying strategy for pharmaceutical companies written by Azzur’s Director of Cleaning Validation, TJ Woody. Get the comprehensive approach by downloading this free whitepaper: https://azzur.co/3s2FaXY #FDA #CleaningValidation #FDACompliance #USFDA #QualityAssurance #Pharma
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Discover the steps to establish a compliant speakers bureau in the pharmaceutical industry, such as navigating regulatory frameworks and content review processes. In our recent blog, learn how Clear Point Health ensures integrity to legal standards. #Pharma https://bit.ly/3V5rhCR
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Check out my blog post https://wix.to/zUs9ano #newblogpost Navigating the complex interplay between state and federal laws in the pharmaceutical industry. Discover key insights from the recent Eighth Circuit case. Share your thoughts! 💡 https://wix.to/9U72BIS #StateVsFederal #LegalPreemption
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A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the U.S. Food and Drug Administration pertaining to drugs was conducted. 195 (85.2%) drugs and 34 (14.8%) medical devices were recalled by the FDA from January 2017 to September 2019. These recalls mostly occurred within smaller companies, but 28 (12.2%) drug recalls were issued against a consensus top 20 pharmaceutical company. Read the full blog here: https://lnkd.in/gKWdxNra #fda #recallmanagement #medicaldevice #smarteeva #Drager #universalmeditech
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Download our case study to learn how IQVIA helped an EU-based pharmaceutical company to navigate the complex world of regulatory compliance. https://bit.ly/3VoNzzF #RegulatoryCompliance #RegulatoryAffairs #RADDS
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Read the 2023 FDA CDER Office of Pharma Quality Annual Report!
Today, FDA’s Office of Office of Pharmaceutical Quality (OPQ) published its 2023 Annual Report, which details the many ways OPQ assures the availability, safety, and efficacy of every dose of medicine available to the American public: https://lnkd.in/ezPkUHgY
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Did you know that on January 1, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) is launching the International Recognition Procedure (IRP)? The IRP aims to facilitate the UK registration of pharmaceutical products post-Brexit. ✔️ Interested in this topic? Read our article to explore this new IRP, and learn how to navigate regulations and the IRP's two assessment routes for streamlined medicine registration in the UK. 💊 #Pharma #IRP #MedicinalProducts #MHRA #UK 👉 https://hubs.li/Q02c00gl0
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By combining FDA regulations and recommendations with pharmaceutical industry standards, this guide will help facilities understand the FD&C Act Section 503B requirements, while providing the tools and rationale for implementing effective processes. Get the Guide: https://bit.ly/3srTnxL #ISPE #503b #Compounding
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By combining FDA regulations and recommendations with pharmaceutical industry standards, this guide will help facilities understand the FD&C Act Section 503B requirements, while providing the tools and rationale for implementing effective processes. Get the Guide: https://bit.ly/45MWiza #ISPE #503b #Compounding
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Thank you for posting! Looking forward to future conversations!