Marcin Bos’ Post

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

Pharmaceutical businesses still face drug and medical supply shortages throughout the industry. This article identifies three main trends impacting the industry in 2024: ongoing drug shortages, federal oversight and the Drug Supply Chain Security Act. #pharmaceuticals #supplychain

🔎 Case Study: Enhancing Pharma Supply Chain Transparency 🔍 A federal agency needed a solution to track the origins of pharmaceuticals and ingredients to mitigate risks and ensure compliance. Our solution mapped the supply chain for the FDA's Essential Medicines, identified origins, and provided critical transparency. See what else it did to boost the agency’s supply chain resilience: https://lnkd.in/gdi-_yhP #SupplyChain #Pharmaceuticals #RiskManagement #CaseStudy #1Exiger

📢The Food and Drug Administration has released a guidance for industry titled “Controlled Correspondence Related to Generic Drug Development”.   📝This comprehensive Guideline outlines the procedure for generic drug manufacturers and related stakeholders to submit controlled correspondence to the FDA, seeking vital information concerning generic drug development.   🔍The guidance delineates the FDA’s process for communicating responses to such inquiries, ensuring clear and efficient communication channels. Additionally, it details the procedure for requesting clarification on any ambiguities in the FDA's responses, emphasizing transparency and understanding.   This guidance represents a significant revision of the previous version issued in December 2020.   #FDA #GenericDrugDevelopment #Guidance #Innovation #PublicHealth #IndustryUpdates #Pharmaceuticals #Healthcare #FDARegulations

What are the unintended consequences of the Inflation Reduction Act on clinical development towards subsequent indications? Find out more about the crucial aspects impacting the pharmaceutical landscape and the broader health care industry. A must-read for professionals navigating the complexities of drug development and regulatory policies! Read more here: https://lnkd.in/ewmgGz-r #ClinicalDevelopment #HealthcareInnovation #Pharmaceuticals #RegulatoryPolicies #DrugDevelopment

State Alert ❗ New Mexico has recently passed a drug price reporting bill set to take effect in 2025. 💊 Are you ready for the changes ahead? While there's still time to gather data, it's never too early to ensure your processes are in place for submitting annual reports and new drug reports. At G&M, we foresee this trend expanding to more states in the near future. Stay ahead of the curve and ensure compliance by preparing now. 📝 #CompliancePreparation #PharmaIndustry #GMHealth #ComplianceMatters #TrustedPartner #Pharmaceuticals

Stay informed with the latest from the FDA! The FDA has issued a Technical Conformance Guide to assist registrants of drug establishments in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. This guide is a crucial resource for industry professionals, providing clear instructions on how to access the FDA’s CDER NextGen Portal and submit these reports. Stay ahead of the curve by understanding the data elements to be included in the reports. #fda #fdacompliance #pharmaceuticals #regulatorycompliance #drugmanufacturing #shenclinicalservices Read More: https://lnkd.in/eg7qD3ZY

"Empowering pharmaceutical safety: Embracing enhanced drug distribution security at the package level under the Drug Supply Chain Security Act. 🛡️💊 Explore industry guidance, ensuring a safer and more transparent drug supply chain. #DrugSafety #SupplyChainSecurity #Pharmaceuticals