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Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing

Fierce Pharma

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. | It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. Since the first wave of consolidation started in 1988, there has been a significant concentration of the pharma industry.

Pharma 100
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How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

Supply chain shortages have dominated headlines for several months, and the pharma industry has been no exception. The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems.

Pharma 88
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New Research Reveals Three Ways Pharma Can Better Prioritize Payer Audiences

PM360

The pandemic had a huge impact on the way population health decision-makers (PHDMs) navigate our industry, and now that it’s clear many of these shifts are here to stay, pharmaceutical manufacturers need to adjust accordingly. We get so little comparative effectiveness data from pharma.” References: 1.

Pharma 92
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Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Hedley Rees has written a book on pharma supply chains that is eye-opening and downright scary. Can patients really be confident in pharma supply chains? Why would a pharma company take risks like these? Patients should be scared.

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New FDA Product-Specific Draft Guidances Available for Generic Drug Development

Pharma Leaders

The FDA has released 25 new product specific guidances (PSG) and 21 newly-revised PSGs that the agency provides to assist generic pharmaceutical manufacturers to develop drugs and generate the evidence needed to support ANDA approvals.

FDA 52