PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act
Rho
On your radar > Patient safety
Patient safety
 | Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations. |
Interactive map of EMA GCP inspections from 2000-09
22-Dec-2010 - Outsourcing-Pharma presents an interactive map showing EMA GCP inspections from 2000 to 2009 by type, routine and triggered, and year.
Big pharma is biggest defrauder
21-Dec-2010 - Big pharma has eclipsed the defence industry as the biggest defrauder of the US federal government under the False Claims Act (FCA), say researchers.
DPI to set up FIH unit at Phoenix hospital
16-Dec-2010 - US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
News in brief
PRA sets up Prague Ph I unit
16-Dec-2010 - PRA International has opened a new Phase I unit in Prague in the Czech Republic, continuing its recent expansion programme.
Celerion acts to meet demand for hospital-based US trials
14-Dec-2010 - Celerion is partnering to access a medical centre Phase I unit that will support increased demand for trials conducted at US hospitals.
Pfizer sought corruption links to end Trovan case; WikiLeaks
13-Dec-2010 - Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.
EMA inspects fewer than 1% of clinical trial sites
13-Dec-2010 - The EMA inspects fewer than 1% of trial sites. Outsourcing-Pharma visualises this data and details the GCP-compliance sampling and collaboration strategies used by the EMA.
PSM forms affiliate to tackle counterfeits in India
09-Dec-2010 - The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
Urgent changes needed to harmful & wasteful ICH GCP
08-Dec-2010 - An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
Complex supply chain driving shift in analytical methods
02-Dec-2010 - The shift towards a complex global supply chain incorporating many suppliers and service providers is driving adoption of modern analytical methods to ensure quality.
Exclusive interview
‘Guinea piggers’ at large in the pharmaceutical industry
30-Nov-2010 - Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
WuXi posts strong Q3; highlights GLP tox services at AAPS
24-Nov-2010 - Demand for drug discovery, development services and active pharmaceutical ingredients (APIs) were the main growth drivers in Q3 according to Wuxi Pharmatech.
Manufacturing of ONSOLIS is all go, says BioDelivery Sciences
24-Nov-2010 - Production of BioDelivery Sciences International’s (BDSI) chronic pain treating drug, ONSOLIS, has resumed after a temporary voluntary shut down at contract manufacturers, Aveva Drug Delivery Systems.
Latin American sites recruit 91% more patients than US
23-Nov-2010 - Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
J&J recall thousands of vials of anti-cancer drug Velcade
22-Nov-2010 - Johnson & Johnson and Millennium Pharmaceuticals have recalled several thousand vials of the anti-cancer drug, Velcade following reports of white particles floating in the medicine.
Industry, innovation & Viagra-stuffed teddies at AAPS
22-Nov-2010 - Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
India tightens clinical trial guidelines
18-Nov-2010 - India’s Central Drugs Standard Control Organization (CDSCO) has drawn up guidelines for regulators and sponsors to help tighten up clinical trial inspection procedures.
“Significant effort” by FDA boosts post-marketing progress
10-Nov-2010 - The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
Human tissue use in preclinical development could cut attrition rates, says Biopta
03-Nov-2010 - Inaccurate predictions based on animal models are the biggest cause of clinical failure according to Scottish CRO Biopta, which says use of human tissue samples for preclinical development would cut attrition rates.
Minipigs a practical, flexible model for toxicology; report
02-Nov-2010 - Minipigs are a practical and flexible model for safety testing which probably provide better prediction of toxicity in humans than rats and dogs, according to EU funded research.
Focus on funding FDA overseas clinical trial policing, says ACRO
29-Oct-2010 - ACRO wants the US FDA’s overseas offices to play more of a role in monitoring clinical trials, and is calling for an additional $35m (€25.3m) to fund the work.
Ethics & trial execution skills critical for Indian CRAs
26-Oct-2010 - Indian CRAs need knowledge of ethics, clinical trial execution and general topics, such as the drug development process, according to a survey into training needs.
FDA adverse event revisions a positive step, says CEO
21-Oct-2010 - Revision to FDA guidance on adverse event reporting is a positive step and forms part of a welcome increased focus on safety, says the CEO of Prism Ideas.
Ethics training guide created for use in low-resource areas
13-Oct-2010 - Easily translatable and adaptable simplified clinical research ethic training guidelines have been created to support field workers in low-resource settings.
FDA clarifies reporting of adverse events in clinical trials
29-Sep-2010 - The FDA has issued a final rule and draft guidance that clarifies what clinical trial safety information must be submitted to the agency.
Supplier Webinars
Technical Papers
- Effective Controlled Substances Supply Chain Management
DPT Labs - Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain
World Courier - The new product development reality
Parexel - Implementing LEAN Techniques in Quality Control
Baxter - A Clinical Perspective on IV Medication Delivery
Baxter - SGS-Clinical-Influenza Clinical Trials…
SGS - Sample Prep Proposed USP<233> Elemental Impurities
SGS - The Scientific Path to Cycle Development
Baxter - Risk-Reducing Solutions for Global Study Logistics
World Courier