Quality Systems

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER) held a public meeting on Oct. 2 to discuss over-the-counter (OTC) cough and cold medications for pediatric use.

Decision Delayed for Pediatric Cough and Cold Meds

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of  a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients.

EFCG and IPEC Europe Establish an Excipient Certification Project

A recent report shows a decline in NASs and a rise in NME applications in 2007.

Trends: NAS Launches and NME Approvals Rise and Fall

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Manufacturers seek real-world benefits from investment in QbD and risk-management strategies. This article contains bonus online-exclusive material.

FDA Proposes Flexible Oversight for Quality Systems

Henning Gieseler, PhD, works in the Department of Pharmaceutics at the University of Erlangen, Erlangen, Germany 91058. tel. +49 9131 85 29545, gieseler@freeze-drying.eu.

Tony Kramer works at the Ecolab Research Center in Eagan, Michigan.

Stefan Schneid works in the Department of Pharmaceutics at the University of Erlangen in Erlangen, Germany.

Cycle design and robustness testing using advanced process analytical technology.

Peer-Reviewed Technical Note: Quality by Design in Freeze-Drying

A new study concludes that an approval pathway for affordable follow-on biologics should be based on the Hatch–Waxman Act of 1984.

Study Promotes Hatch–Waxman Model for Biologics Exclusivity

Companies launched 25 new active substances in 2007, a decline of 19% from the previous year, according to a new report from Parexel International.

NAS Launches and NME Approvals Declined in 2007

The US Food and Drug Administration will hold a public meeting this month to gain public input on implementing the recommendations of the Nanotechnology Task Force report, taking another step closer to setting a regulatory framework for nanotechnology for pharmaceuticals and medical devices.

Setting a Regulatory Framework for Nanotechnology

Filip Vanhoutte is an associate director of drug-product development at Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium, tel. +32 0 14 60 39 58, fax +32 0 14 60 5333

Luc Janssens is senior director of global regulatory affairs at Tibotec.

Guy Smans is a principal scientist in drug-product development at Johnson & Johnson Pharmaceutical Research and Development.

Marc Vanstockem is senior director and chemicalâpharmaceutical team leader at Tibotec.

Criticality management combines pharmaceutical product, process, and material knowledge and risk management in one approach, which is reflected in a single document.

Criticality Management of a Drug Product and its Manufacturing Process

The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use.