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STAT+: FTC says pharmacy benefit managers are stonewalling requests for information

STAT

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. A much-anticipated inquiry by U.S.

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Strategic EPCIS Implementation: Optimizing Supply Chain Management through Strategic EPCIS Implementation

Pharmaceutical Commerce

This document outlines key strategies and testing protocols critical for optimizing EPCIS implementation, ensuring that pharmaceutical manufacturers can maintain compliance and operational efficiency.

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Drop Shipment Efficiency: Navigating Data Challenges in Indirect Partner Transactions

Pharmaceutical Commerce

This document details the benefits of DataX, a revolutionary solution tailored for pharmaceutical manufacturers. Designed to navigate the complexities of managing serialized data for drop shipments, DataX ensures secure, compliant, and efficient data exchange.

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PDA releases contamination control strategy report

European Pharmaceutical Review

The Parenteral Drug Association (PDA)’s long-awaited Technical Report 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing is now available. Key features of the PDA TR 90 report The document addresses the evolution of contamination control principles towards a holistic approach.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively. Overall, validation, documentation and quality control were the major cGMP violations.

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STAT+: ‘It’s beyond unethical’: Opaque conflicts of interest permeate prescription drug benefits

STAT

Or they may share in the rebates that the PBMs pluck from pharmaceutical manufacturers — money that otherwise could be used by employers to lower premiums for their workers. Consulting firms and brokerages may receive a certain dollar amount for each covered employee and member.

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FDA warning letters highlight data integrity issues

European Pharmaceutical Review

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.