The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
The FDA is still in “the early stages” of overseeing 503B outsourcing facilities, but efforts continue as concerns surround the oversight of drug compounders, according to a recent report by the US Government Accountability Office (GAO).
Scientists developing vaccines for potentially deadly diseases like influenza, SARS and HIV struggle to find a CRO with the right capabilities according to contractor TNO Triskelion.
Chinese API firm Shenzhen Hepalink has announced plans to buy Scientific Protein Laboratories (SPL) from private equity investor American Capital for $337.5m.
Greater FDA oversight of US manufacturing plants increased the number of drug recalls in Q3 in a trend that is likely to continue according to a new report.
Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
The US FDA’s Puerto Rico office may be “having difficulty” monitoring drug manufacturing in the country according to the Congressional Committee on Oversight and Government Reform.
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.
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.
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.
A strategic partnership between New England IRB (NEIRB) and Veritas IRB of Montreal will see their clients following a common protocol review for studies they conduct throughout the US and Canada.
The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics review.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
FDA warning letters to clinical trial investigators have increased by 50 per cent in 2009 as a consequence of improved processes at DSI, a spokesperson told Outsourcing-Pharma.
in-PharmaTechnologist assesses the scale of the challenge facing the FDA in effectively monitoring overseas facilities, using interactive graphics and textual analysis.
Coast IRB has decided to close after a probe by US Government Accountability Office (GAO) and subsequent FDA warning letter resulted in the loss of “several key customers”.
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.
The US Food and Drug Administration (FDA) is pushing for Congress
to approve the use of more third-party inspectors as the regulatory
body attempts to police a complex global supply chain.
