Viewpoints

In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.

Advances in medicine and consumer electronics can enhance drug delivery and patient care.

Sharing know-how can help resolve common bio/pharma technical challenges.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.

After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

A skilled workforce is needed to deliver on technology’s promising medical advances.

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

New therapies and tighter budgets challenge bio/pharma to think outside the industry.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.

FDA enforcement efforts and drug approvals trend upward.

Hospitals form not-for-profit drug company to combat drug shortages and high prices.

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.

Bio/pharma professionals manage expectations amid industry uncertainty.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Is pharma up to the task of developing knowledgeable, motivated employees?

Industry experts were honored for business, scientific, and social contributions.

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Six years after the guidance, it’s time to change our quality assurance vocabulary.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

Faced with divisive political and social issues, Congress must find a way to reach consensus.