Quality Systems

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.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.