Remove 2025 Remove Documentation Remove Pharmaceutical Manufacturing
article thumbnail

Navigating 340B Program Changes in 2025

Proxsys Rx

billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceutical manufacturers 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.

article thumbnail

AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

AI-driven biomanufacturing: revolutionising production and quality in pharmaceuticals

European Pharmaceutical Review

Over the next few years, there are virtually no aspects of pharmaceutical manufacturing 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.

article thumbnail

Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Implementing PAT in (bio)pharmaceutical manufacturing 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.

article thumbnail

DOP amends PTUAS, expands eligibility criteria to include MSMEs

Express Pharma

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 pharmaceutical manufacturing units with an average turnover of less than Rs. Documentation is an altogether different skill without which compliance is not possible.

article thumbnail

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics

Putting Patients First Blog

NHC Submits Comments on FDA Draft Guidance on AI to Support Regulatory Decision-Making for Drugs/Biologics (PDF) April 7, 2025 Dockets Management Staff U.S. 12 To this end, the NHC encourages the FDA to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.

article thumbnail

DSCSA

Ramblings of a pharmacist

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?