Quality Systems

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

The agency prepares a plan to implement new packaging safety features.

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

The author reviews FDA's final Animal Rule guidance.

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

Can the feds negotiate Medicare Part D prices?

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies.

Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.

The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

Amgen announces FDA will review the company’s BLA for ABP 501.