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Set Alert for Manufacturing

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.

Europe United States Manufacturing

Latest From Manufacturing

Will Biosimilars Lead To Better Biologics Manufacturing?

US FDA Commissioner Gottlieb is promising new policies to improve biologics manufacturing as part of agency’s action plan to accelerate biosimilar development. That follows the pattern set 25 years ago with generic drugs and brand manufacturing. 
Biosimilars Manufacturing

US FDA Quality Metrics Initiative Continues Moving Forward … Quietly

Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.
Compliance Manufacturing

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.

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