The US Food and Drug Administration (FDA) has released a draft
guideline document outlining a model for implementing the
International Conference on Harmonization's (ICH) Q10.
Outsourcing-Pharma.com compiles the news that featured in the
clinical contract community this past week, involving Encorium,
Amarex, Paragon Biomedical, Pacific Biometrics and Parexel.
The European Commission has released figures showing that there has
been a dramatic and concerning increase in pharmaceutical
counterfeiting, with seizures in Europe hitting an all time high of
over 2.5m items.
China has today sentenced to death the former director of its State
Food and Drug Administration (SFDA), on charges of corruption,
according to reports in the Chinese media.
An online database detailing information on all manufacturing and
importation certificates and authorisations issued within the
European medicines network has been launched by the European
Medicines Agency (EMEA).
Bridge Pharmaceuticals has just launched a new training scheme
between its facilities in the US and China to enable its employees
to cross train in both labs - a potential competitive advantage for
a contract research organisation...
A new study condemns the high prevalence of ghost writing in
pharmaceutical company-sponsored clinical trials and calls for the
controversial practice to be culled in order to improve
transparency.
A number of executives and technical staff at small to medium size
pharmaceutical firms are unaware of how to use their resources
effectively to comply with new EMEA guidelines, designed to
minimise the environmental impact of compounds,...
Pharmaceutical companies are beginning to catch up with other
industry sectors that take an increasingly realistic view of what
they consider a core competency and outsourcing what is left -
Outsourcing-Pharma takes a snapshot of...
China is a big market with a lot of potential but many pharma
industry firms still avoid doing business in the country because of
fears that their intellectual property (IP) cannot be protected.
Two trade associations of the world's two largest pharma economies
- Europe and the US - took the unusual step of banding together at
the CPhI in Paris to condemn their regulatory authorities for poor
regulation of foreign active...
A draft guidance has been published by the Food and Drug
Administration (FDA) to help the industry wade through the
potential minefield of conducting clinical research on patients
without informed consent, in cases of emergencies.
The clinical trials industry is struggling to cope with the burden
of maintaining adequate drug accountability documentation for
regulatory compliance.
Dalton Pharma Services has introduced a range of new medicinal
chemistry services that are available to companies involved in drug
discovery that wish to utilise additional scientific and managerial
expertise as well as specialised...
Researchers have published a new article launching a scathing
attack on the growing incidence of healthcare professionals being
paid exuberant 'finder's fees' whenever they recruit a patient onto
a clinical trial.
The Food and Drug Administration (FDA) will beef up its process for
disclosing the conflicts of interest of its advisory experts in a
bid to restore its reputation after a survey suggests its
scientists may be too closely tied with...
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has announced a series of
new policy and regulatory developments to modernise the way it
monitors clinical trials and bioresearch.
The US Food and Drug Administration (FDA) has outlined a series of
imminent changes to the way it evaluates clinical trials in an
attempt to clamp down on fraud.
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has signalled it will
soon allow a new "adaptive" approach to clinical trials in order to
streamline drug testing and speed drugs to market.
Outsourcing-Pharma.com focus on: cutting the cost of clinical trials
Outsourcing-Pharma.com sheds some light on how pharma companies can
make sure they are choosing a contract research organisations (CRO)
that will stick to the rules of ethics when running clinical trials
in poorly-regulated countries...
Outsourcing-Pharma focus: cutting the cost of clinical trials
After recent allegations in the media that poor and illiterate
patients in India are being used, often unknowingly, as human
guinea pigs to test new drugs for the pharma giants of the West,
Outsourcing-Pharma takes a look at how cutting...
The World Health Organization (WHO) has announced details of a new
initiative compelling drug companies to register all clinical
trials on humans after public pressure for more transparency.
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration's (FDA) drive to clear the
mounting backlog of post-marketing (Phase IV) drug trials signals
good news for the clinical research organisations (CROs) who are
poised to benefit.
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration (FDA) is investigating ways
of boosting the completion rate of new drug post marketing
commitment studies in the wake of ongoing controversy over the
agency's lack of enforcement. The answer,...
Asia and India are continuing to attract a wave of foreign
outsourcing contracts in the pharma industry, as companies are
lured by productivity-and cost savings. However, these countries
are not yet reaching their potential, as fears...
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...
