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billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceuticalmanufacturers which could further strain the healthcare safety net and patient care services. As we enter 2025 Q2, the sad truth is that most 340B hospitals are struggling to protect their programs from further prescription-savings erosion.
What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceuticalmanufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.
Over the next few years, there are virtually no aspects of pharmaceuticalmanufacturing processes that will not be changed by artificial intelligence (AI). This helps manufacturers navigate the complex regulatory landscape while ensuring their products meet all necessary requirements.
Implementing PAT in (bio)pharmaceuticalmanufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility.
300 crore, over the next two fiscal years (150 units each in 2024-25 and 2025-26). The intended beneficiaries are now specified as existing pharmaceuticalmanufacturing units with an average turnover of less than Rs. Documentation is an altogether different skill without which compliance is not possible.
NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. 12 To this end, the NHC encourages the FDA to establish clear expectations for how sponsors validate and document AI-driven findings that are submitted as part of the regulatory dossier.
As I’ve discussed before on this blog, counterfeit products DO exist and even have the apparently appropriate T3 documents to validate their legitimacy. If I’m a pharmacy operator, what do I actually need to do to make sure that I don’t get a fine in 2025 for failure to comply with DSCSA?
Nicholas Saraceno Key Takeaways DSCSA enforcement deadlines are phasing in through 2025 , with wholesalers and repackagers already required to comply as of May 27, and wholesale distributors facing an August 27 deadline—provided they show active progress on data connections. Nicholas Saraceno is Pharmaceutical Commerce's Editor.
On January 5, 2025, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 13 of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, focusing on materials, reference standards and vendor qualification.
Published June 5, 2025 Amy Baxter Staff Reporter post share post print email license FDA Commissioner Martin Makary attends a Senate Appropriations Committee hearing May 22, 2025. Questions remain The FDA will plan to focus Elsa’s scope on administrative tasks such as summarizing documents and data extraction.
Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceuticalmanufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) 62,094, 62,097 (Oct.
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