16-Oct-2013 - The US FDA has released the ICH’s guideline on elemental impurities for public comment a little more than two months after the ICH did the same.
15-Oct-2013 - Pharma Action says safety of supply will counter the low costs of Chinese made heparin as it inks a joint venture with the Tönnies Group.
14-Oct-2013 - The Ghanaian FDA has defended its decision to ban all imports from India' Bliss GVS amid growing industry concerns about the speed of the agency's decision making.
07-Oct-2013 - Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.
03-Oct-2013 - A new range of culture media dishes cut contamination risk during analysis of facility microbiological QC samples says developer Sartorius Stedim Biotech (SSB).
02-Oct-2013 - Sartorius Stedim Biotech (SSB) has launched a new range of culture media dishes designed cut the risk of contamination during lab analysis of facility microbiological QC samples.
01-Oct-2013 - Indian drug manufacturer Aarti Drug Limited was hit with a warning letter from the US FDA this summer after the agency found multiple cGMP violations.
01-Oct-2013 - The US government is set to shut down at least temporarily and the US FDA will see about half of its staff furloughed.
30-Sep-2013 - The US House on Saturday passed legislation that calls for the tracking and tracing of pharmaceuticals through the nation's supply chain after agreeing on the bill with the Senate last week.
26-Sep-2013 - After nearly 50 years in use, UK’s MHRA is now looking into whether it should update and replace its system for reporting drug side effects to increase incident reporting and decrease confusion.
24-Sep-2013 - The use of "flaking" and non-sterile gloves in aseptic processing, as well as cGMP violations, has led to the the US FDA issuing a warning letter to Agila for its Bangalore, India plant.
24-Sep-2013 - Pharma Technology Inc. (PTI) says its new deduster offers tablet manufacturers more flexibility with greater residual powder being removed due to its polymer spiral.
24-Sep-2013 - Pfizer, GlaxoSmithKline, Sanofi, and at least ten other big pharma companies, CMOs and industry groups are criticizing aspects of the recent FDA draft guidance governing quality agreements.
24-Sep-2013 - A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.
19-Sep-2013 - The California Board of Pharmacy is proposing to amend the state pharmaceutical track-and-trace legislation to exempt wholesalers from e-pedigree requirements in cases where manufacturers directly ship drugs to pharmacies.
17-Sep-2013 - Recently acquired tech firm Sepha has launched a new non-destructive leak testing system for pharmaceutical bottles.
17-Sep-2013 - After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
16-Sep-2013 - After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
16-Sep-2013 - Johnson & Johnson is battling another onset of quality concerns as its subsidiary Janssen is pulling one lot of its Risperdal Consta injection in the US due to a mold contamination.
12-Sep-2013 - Regulators in Southeast Asia say draft process validation guidelines issued for consultation last week are a work in progress and likely to change as discussions continue.