04-Nov-2010 - Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
03-Nov-2010 - in-PharmaTechnologist presents interactive charts visualising FDA overseas inspections by type and year, as well as the proportion of sites that may never have been inspected.
02-Nov-2010 - Agilent Technologies has opened a new instrument plant in Singapore to boost capacity for LC/MS production and drive expansion across Asia.
02-Nov-2010 - Biopharm are increasingly assessing the threat counterfeiting and diversion pose to emerging biotechs when planning an acquisition, according to a white paper.
02-Nov-2010 - Pfizer has widen its recall of the cholesterol-fighting drug, Lipitor, after two more complaints of a musty odour emanating from the product’s bottles.
28-Oct-2010 - Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.
27-Oct-2010 - The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.
27-Oct-2010 - UK-drugmaker GlaxoSmithKline (GSK) must pay $750m to settle a law suit criticising manufacturing practices at plant in Cidra, Puerto Rico that was shut down in 2009.
26-Oct-2010 - Rx-360 expects membership numbers to “snowball” in the coming year as it looks to build on progress made in establishing the consortium.
25-Oct-2010 - The United States Pharmacopeial Convention (USP) and six government drug control laboratories in the Middle East and Northern Africa (MENA) join to launch a drug quality improvement Network.
21-Oct-2010 - iGPS is offering what it claims is the world’s first pallet rental service to supply plastic pallets with embedded radio frequency identification (RFID) tags to the pharmaceutical and life sciences industries.
21-Oct-2010 - The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.
20-Oct-2010 - Johnson & Johnson (J&J) recalls another 128,000 bottles of its over-the-counter painkiller, Tylenol, after new complaints of a “mouldy odour.”
19-Oct-2010 - A week of global anti-counterfeiting law enforcement coordinated by Interpol led to the shutdown of 290 websites, seizure of 11,000 packages and confiscation of 1m pills.
14-Oct-2010 - The FDA is to collaborate with the WHO to build a global surveillance and monitoring system for combating falsified medicines and breaches of the supply chain.
13-Oct-2010 - New ‘chiral center’ in Belgium promises to help drug firms comply with regulatory demands for quality and accelerate registration of new compounds.
13-Oct-2010 - “Musty smells” associated with three Lipitor bottles indicate a problem within the supply chain, says Rexam of Las Piedras, Puerto Rico, who were confirmed by Pfizer as the “third-party recalling supplier.”
12-Oct-2010 - Guy Villax, board member of the EFCG, talks falsified APIs, EU efforts to tackle the issue, and the presence of gangsters in the pharma industry in an in-PharmaTechnologist video interview.
11-Oct-2010 - Pfizer says low levels of 2,4,6 tribromoanisole were detected in seven lots of the cholesterol buster, Lipitor, that it recalled in August.
05-Oct-2010 - Gilead Sciences has received a warning letter from the US Food and Drug Administration (FDA) concerning manufacturing problems at the San Dimas, California, plant, where HIV medicines are made.
29-Sep-2010 - The US FDA and NIH are funding research into bioinformatics-modelling of nanoparticles as part of a collaborative initiative to advance regulatory science.
28-Sep-2010 - RTS Life Science has formed a Pharmaceutical Testing Group to integrate UK developed products for inhaler and tablet testing with US developed products for dissolution and content uniformity testing.
21-Sep-2010 - Pall is launching the GeneDisc Rapid Microbiology System for quicker microbial quality monitoring and improved production efficiency.
20-Sep-2010 - The US FTC has given a positive advisory opinion to Rx-360’s shared audits and said the programme appears to offer “cognisable cost-saving and safety enhancing features”.
15-Sep-2010 - The US FDA has warned Bristol-Myers Squibb (B-MS) about significant GMP violations at plant in Manati, Puerto Rico, including a failure to establish anti-contamination protocols.