18-Dec-2019 By Nick Taylor
The US FDA attributes decline in foreign inspections from 2016 to 2018 to inability to fill vacancies.
18-Jan-2017 By Gareth Macdonald
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.
28-Nov-2016 By Melissa Fassbender
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).
03-Mar-2014 By Gareth Macdonald
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.
07-Jun-2012 By Nick Taylor
The US FDA has sent warning letters to eight biopharma companies for failing to register production facilities.
18-Apr-2012 By Nick Taylor
The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.
19-Dec-2011 By Nick Taylor
Manufacturers of certain critical drugs must report production interruptions to the FDA under a new interim final rule.
FDA anti-adulteration efforts hindered by industry; GAO
28-Nov-2011 By Nick Taylor
Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.
Greater FDA inspection role increased drug recalls in Q3, study
07-Nov-2011 By Gareth Macdonald
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.
FDA must be empowered to oversee supply chain; report
13-Jul-2011 By Nick Taylor
Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.
Chimerix drops BARDA protest after contract modification
04-Jul-2011 By Nick Taylor
Siga Technologies can resume work on scale-up of a smallpox antiviral after Chimerix dropped its protest following a contract modification.
Protest against award of US gov contract suspends work
16-May-2011 By Nick Taylor
Work towards manufacturing scale-up of a smallpox antiviral has been suspended after a protest was filed against award of the US government contract.
FDA to amend trial investigator disqualification regulations
18-Apr-2011 By Nick Taylor
The FDA is planning to change clinical investigator disqualification regulations following GAO recommendations.
Foreign inspection worries keep FDA on GAO risk list
The GAO has again included the FDA in its high-risk series because of shortcomings in the oversight of overseas manufacturing facilities.
Top regulation & enforcement articles of 2010
23-Dec-2010 By Nick Taylor
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.
No inspections of heparin sites in China in 20 months pre-crisis
10-Nov-2010 By Nick Taylor
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.
FDA may be having difficulties in Puerto Rico, says US oversight cmttee
09-Nov-2010 By Gareth Macdonald
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 shorten inspection times during crises
04-Nov-2010 By Nick Taylor
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 By Nick Taylor
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 bring benefits but planning needed
28-Oct-2010 By Nick Taylor
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.
FDA may never have inspected 88 per cent of Chinese sites
27-Oct-2010 By Nick Taylor
The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.
IRB development: partnership between NEIRB and Veritas IRB
18-Oct-2010 By Emily Dobell
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.
FDA taking more cautious approach to non-inferiority trials
30-Aug-2010 By Nick Taylor
The FDA is taking a more conservative approach to data from non-inferiority trials when reviewing NDAs, according to a GAO report.
AAHRPP revises standards
01-Oct-2009 By Nick Taylor
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.
CROs alter IRB selection policies after GAO sting; VP
23-Sep-2009 By Nick Taylor
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.
09-Sep-2009 By Nick Taylor
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.
Policing the globe – the scale of FDA overseas inspections
18-May-2009 By Nick Taylor
in-PharmaTechnologist assesses the scale of the challenge facing the FDA in effectively monitoring overseas facilities, using interactive graphics and textual analysis.
Coast IRB closes doors after GAO sting
27-Apr-2009 By Nick Taylor
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”.
Coast IRB suspends ops following GAO probe
15-Apr-2009 By Nick Taylor
Coast IRB, the company targeted in a recent undercover operation by the GAO, has suspended operations following a warning letter from the FDA.
14-Jan-2009 By Gareth Macdonald
Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.
Further twists in heparin scandal
26-Nov-2008 By Nick Taylor
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”.
GAO critical of FDA’s overseas inspections
23-Oct-2008 By Nick Taylor
A report has been published detailing the US Food and Drug Administration’s (FDA) failings in its inspection of overseas manufacturing facilities.
FDA to outsource manufacturing inspections
17-Jun-2008 By Nick Taylor
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.
FDA falling down on device inspections, says GAO
14-Feb-2008 By Pete Mansell
The US Food and Drug Administration (FDA) has once again been
accused of failing in its duty to protect the American public.
FDA failure on foreign inspections frightening
05-Nov-2007 By Kirsty Barnes
A US government audit has confirmed the Food and Drug
Administration's (FDA's) continual lack of inspection of foreign
drug manufacturing plants.