Good overview of 2023 new drug approvals and released guidances.
FDA’s Office of New Drugs (OND) issued their 2023 Annual Report highlighting OND’s successful year for novel drug approvals and other drug development activities that help advance the health of the American public: https://lnkd.in/e7udSaNW
Take a look at the remarkable achievements of the Office of New Drugs (OND) for 2023! This annual report from the OND details groundbreaking drug approvals for rare diseases to diverse efforts in managing chronic disorders and combating infectious diseases! See the full report below. #OfficeOfNewDrugs | #PublicHealth |#HealthcareInnovation |#RegulatoryScience | #DrugDevelopment | #PatientCare | #FDAApprovals
FDA’s Office of New Drugs (OND) issued their 2023 Annual Report highlighting OND’s successful year for novel drug approvals and other drug development activities that help advance the health of the American public: https://lnkd.in/e7udSaNW
We just released our July Pipeline Report! 🚀✨ This comprehensive report offers insights into recent drug approvals, products on our radar, and more! 📊🔍Get your hands on the full report: https://bit.ly/4frsUEg #pipelinereport #newmedications #fdaapproved #specialtypharmacy
Is supply chain the reason of high price of Medicines in United States? US pay 10x higher prices for prescription drugs despite having 7 companies among top 10 pharma globally!!! Do you know why? There are three main drivers--- 1. No Price Regulator 2. Multiple intermediaries - Opaque Supply Chain 3. Unique Patent Monopoly - Evergreening Discover the shocking truths behind the soaring prices, from complex and opaque supply chains to prolonged patent monopolies. Swipe right to dive in! 📊💊 Share your thoughts or stories in the comments below. Let's start a conversation and raise awareness together! #supplychain #prescriptiondrugsUSA #Pharma #PBMs #HealthInsurance #HighPrice Follow me for more interesting business stories and in-depth case studies.
Join our webinar this week as we unravel the intricacies of leveraging FDA interactions to drive your projects forward. 📑 💡Key Insights: • Understand the distinct features of INTERACT, pre-IND, and Type D meetings and their unique requirements. • Discover when and how to prepare comprehensively for successful interactions with the FDA. • Acquire knowledge on engaging with the FDA to optimize decision-making processes in early drug development. 🔗 Register now to secure your spot: https://lnkd.in/dR5wMDCy Don't miss out on this opportunity to elevate your understanding of FDA interactions! #TrialWithoutBorders #HiRO #FDA #PreIND #RegulatoryWebinar
Full Service Clinical Trial Management | Customized Solutions | Regulatory Expertise | Accelerated Timelines
Expedited Withdrawal of Drugs Approved via the Accelerated Approval Pathway FDA’s Accelerated Approval (AA) pathway has often been a subject of public criticism due to the apparent approval of inefficient drugs based on preliminary and/or partial efficacy data. However, the AA is a conditional approval that can be withdrawn if the conditions are not met. This week, the FDA released a new guidance document whose primary purpose seems to be to show the expedited withdrawal process for AA drugs. Read More: https://lnkd.in/g6gasTPP Author: Dr. Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #drugs #drugsapproved #fdaregulations #fdacompliance
We just released our July Pipeline Report! 🚀✨ This comprehensive report offers insights into recent drug approvals, products on our radar, and more! 📊🔍Get your hands on the full report: https://bit.ly/3A2wTXA #pipelinereport #newmedications #fdaapproved #specialtypharmacy
Join us this Thursday to learn more about product-specific guidance development and assessment for generic topical products!
Calling all professionals in drug development! Our virtual workshop on Generic Topical and Dermal Drug Products is the perfect opportunity to connect with FDA and other experts. You don’t want to miss out! Register: https://lnkd.in/gdr45bC5
Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/3AhPizU #pharmamfg #contractmfg
Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/4dmRzaS #pharmamfg #contractmfg
Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/3Xu5nvN #pharmamfg #contractmfg