article thumbnail

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.

article thumbnail

Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

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

FOPE & PharmaState Academy conducts session 17 on gap analysis and implementation plan for Revised Schedule M

Express Pharma

hour workshop provided participants with direction, supplementary documentation, and hands-on learning, ensuring they were well-equipped to meet compliance requirements. He provided detailed responses on compliance challenges & documentation requirements. Close to 200 participants attended the online workshop.

article thumbnail

Digital Transformation in Pharmaceutical Manufacturing

PharmaTech

Leveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.

article thumbnail

How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.

article thumbnail

FOPE and PharmaState Academy hosts Session 11 of the PULSE series

Express Pharma

He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation. He mentioned the role of quality assurance in ensuring these practices are followed.

article thumbnail

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.