Quality Systems

FDA Posts PDUFA Meeting Minutes

FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release.

A number of European public health and transparency campaigners believe that conflict of interest rules may have been breached with the EMA's decision to allow its former Executive Director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector.

The European Organization for Rare Diseases (EURORDIS), an alliance of patient organizations and individuals, celebrated its fourth Rare Disease Day on February 28.

FDA and Georgetown University Form Innovation Partnership

Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected.

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

What to do when your CMO changes the manufacturing equipment line.

The 2011 show presents ideas for package designs and equipment options for packaging lines.

Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.

A revised book on process analytical technology could be valuable to novices and experts.

Brazil develops its first national plasma fractionation plant.

A single, global tooling standard would offer many benefits, but one has been slow to emerge.

The author describes key considerations for drug manufacturers when evaluating packaging partners.

A new audit guide aims to improve supply-chain security and supplier qualification practice.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Just when things seem to be looking up, the unexpected problem occurs.

The authors review a compliance-by-design approach to quality systems.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

INTERPHEX 2011 aims to address the industry's unique characteristics.

The Society of Chemical Manufacturers and Affiliates (SOCMA), in a statement submitted to the US House Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies, called for Congressional action to pass a three-to-five year authorization of current Chemical Facility Anti-Terrorism Standards (CFATS), which are scheduled to expire Mar. 4, 2011.

Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.

HHS Releases a New National Vaccine Plan

President Barack Obama released his budget proposal for fiscal year (FY) 2012, which shows an increase in funding for the US Food and Drug Administration.

EMA Outlines Activities for 2011, and more.

US Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) introduced the "Preserving Access to Life-Saving Medications Act," which is intended to help address and prevent shortages of prescription drug medications.

My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn?t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?

Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.

The recent India–EU summit was expected to bring news about the upcoming Free Trade Agreement between the EU and India; however, a dispute regarding the supply of generic drugs from India to developing countries has taken centre stage.