Quality/GMPs

FDA releases guidance documents and rules on requirements for compounding human drug products.

Is there potential for growth in Brazil's phytotherapic drug market?

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Supplier Audit Program Marks Progress

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.

With globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.

Challenges in Securing the Biopharma Supply Chain

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

EDQM details the agency?s accomplishments in 2013.

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

FDA issues guidance on the use of social media in regards to prescription drugs.

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

Draft guidance from FDA includes information essential for the completion of ANDA applications.

EMA publishes revised guideline on the acceptability of names for drugs.

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

FDA launches openFDA to provide easy access to FDA public data.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

Brunei harnesses its rich biodiversity and the growing halal market in a bid to develop its pharmaceutical sector.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

EMA opens registration for it's sixth annual workshop on pediatric drug research and development.

FDA and EMA release a draft joint proposal on the development of new drugs to treat Gaucher disease in children.