21-Dec-2011 - Ranbaxy has signed a consent decree with the US FDA and set aside $500m for penalty payments to settle its longstanding dispute.
20-Dec-2011 - Counterfeit anti-malarials containing the Viagra API were probably manufactured in Southeast Asia, researchers found.
19-Dec-2011 - Manufacturers of certain critical drugs must report production interruptions to the FDA under a new interim final rule.
15-Dec-2011 - A treaty on medicine quality is needed to fix the major public health problem of substandard drugs, according to academics.
14-Dec-2011 - The EMA has recommended recalling a batch of Gilead’s Vistide manufactured by Ben Venue over particle contamination concerns.
13-Dec-2011 - The FDA and the EMA will begin sharing facility inspection data in their respective territories from January to make better use of resources and reduce drugmakers’ inspection burdens.
13-Dec-2011 - Hospira says Chairman Christopher Begley’s impending retirement is unrelated to quality problems at manufacturing plant or recent investor criticism.
08-Dec-2011 - Mettler Toledo says its new dissolved oxygen (DO) measuring optical sensors can speed up the API production process and reduce maintenance costs.
05-Dec-2011 - The Ethiopian national quality control laboratory has gained ISO accreditation to improve access to safe medicines.
01-Dec-2011 - Biologics Modular is leasing its mobile production facilities to help clients make FDA regulated drugs without fixed plants.
01-Dec-2011 - The drug industry's need to improve product quality while reducing production costs is driving global demand for testing technologies according to Sepha.
30-Nov-2011 - Novo Nordisk has stopped using living animals in batch quality tests after developing a virus filtration tool for factor VII production.
29-Nov-2011 - USP is creating a China-focused East Asia expert committee to develop quality standards for excipients.
28-Nov-2011 - Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.
23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.
23-Nov-2011 - The US FDA has sent Mylan a warning letter after inspectors found GMP testing failings at its Puerto Rico facility.
21-Nov-2011 - Ben Venue Laboratories has voluntarily suspended manufacture at the Ohio plant linked to drug shortages.
21-Nov-2011 - Real-time release testing can save money by cutting recalls but “fear of the unknown” is limiting use, a FDA official said.
15-Nov-2011 - The USP has forged closer bonds with the Chilean Pharmacopoeia Foundation (CPF) in the latest of a series of agreements with regional drug quality groups.
15-Nov-2011 - Wholesalers’ trust in the quality of products from some countries could decrease vigilance and allow counterfeits to reach pharmacies, research found.
10-Nov-2011 - The US FDA is publishing immediate and modified release QbD examples to help generics companies prepare for full implementation in 2013.
09-Nov-2011 - The FDA is investigating compounding pharmacies’ Makena after K-V Pharmaceutical said they differ from approved forms.
09-Nov-2011 - The EMA plans to update guidance on certification and batch release in response to globalisation of the pharma supply chain.
08-Nov-2011 - The Chinese FDA should hire more CMC reviewers to encourage QbD applications, a Pfizer executive said.
08-Nov-2011 - The US FDA has sent Genentech a GMP 483 after inspectors found failings in the capping process for Avastin.