Quality/GMPs

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

FDA provides recommendations for submitting analytical procedures and methods validation data.

FDA and EMA set up regular meetings to harmonize drug safety actions.

Thirteen companies are accepted for participation in the supply chain program.

EMA releases an update on its flu vaccine guidance.

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.