Quality/GMPs

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.

High technology assessments are having an impact on biosimilars development in Europe.

The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.

ISPE and PDA take on the challenge of recommending quality metrics.

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

In 2013, the EMA's Committee for Medicinal Products for Human Use recommended 81 medicines for human use for marketing authorization, compared with 57 in 2012.

USP opens expanded Shanghai facility to enhance quality standards for medicines and food ingredients.

FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.

FDA releases guidance on the qualification of drug development tools.

Techniques to enable the design and formulation of stable, protein-based therapeutics.

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

Criticality is used as a risk-based tool to drive control strategies.

Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.

Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.

Baxter International recalls dextrose injection and four sodium chloride injections.

FDA and EMA launch initiative to share bioequivalence inspection information.

Agency issues precautionary recall due to manufacturing fault.

Agency issues precautionary recall due to manufacturing fault.

NPS Pharmaceuticals uses its expertise in development, regulatory compliance, and commercialization to bring to market products with orphan drug status.

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

OGD is under pressure to improve review operations.

EMA revises its polices on fee reductions for orphan drugs for 2014.

Drug Quality and Security Act gives FDA authority over compounding pharmacies.

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

Variation understanding and modeling is a core component of modern drug development.

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.