Quality Systems

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

The Hapa 862, from Hapa AG, is a modular, CMYK/spot-color inkjet printing system for the in-line packaging printing of foils and labels.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.

PAT holds the key to real-time quality assurance and consistent product quality in pharmaceutical manufacturing.

The pharmaceutical industry wants to speed up the variations process by eliminating redundant assessment by different national agencies in the European Union.

Will biosimilars share a compendial identity like generic drugs do?

The directorate highlights achievements accomplished during the year of its 50th anniversary.

The restructuring of the International Conference on Harmonization, which is expected to begin in late 2015, could have a significant impact on the way pharmaceutical regulations are harmonized worldwide.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

New guidance complements ICH guidelines on impurities.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Optical inspection equipment for packaging was displayed at INTERPHEX 2015.

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.