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Manufacturing

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Risk-Based Contamination Limits Suggested For Highly Potent Drugs

As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.

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Regulators Encourage Science And Risk-Based Approaches In NDAs For Peptides And Oligonucleotides

Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotides and peptide drugs. They say that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these products, which have flooded the development pipeline.

US States Europe

US FDA Developing Database Of Medical Review Decisions, Gottlieb Tells Congress

'Knowledge management platform' will identify agency's scientific precedents; Commissioner Gottlieb says it is one of FDA's top three initiatives, along with continuous manufacturing and real-time safety monitoring.

Drug Approval Standards Manufacturing

Report: Global API GMP Inspection Coordination Increasing Under Joint Program

Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement.

United States Manufacturing

When Should False Claim Act Complaints Be Dismissed? US Supreme Court Wants Government's Views

Solicitor General to weigh in on Gilead's petition asking court to clarify application of its Escobar decision; PhRMA and BIO say FDA, not jury, should decide whether company has complied with FDCA.

Manufacturing Advertising, Marketing & Sales

Drug Industry Raises ‘Green’ Concerns Over Forthcoming EU Environment Strategy

The European Commission’s strategy on Pharmaceuticals in the Environment is expected to be published by the summer. The pharmaceutical industry has concerns about what it is likely to include.

Europe Manufacturing

Pfizer Contract Manufacturer Slammed By US FDA For Dissolution Failures And Leaking Bottles

Tris Pharma is ultimately responsible for ensuring compliance with GMPs, warning letter states, even if Pfizer helped guide investigation of failed dissolution testing for ADHD drug Quillivant XR.

Manufacturing Quality
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