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Microtest Labs announces new
fast-track toxicity testing for medical devices using Zebrafish embryos
Microtest Laboratories has announced a new fast-track test to
screen plastics and polymers in medical devices for toxicity using Zebrafish
embryos (Danio rerio), a technique already widely utilized in drug development
studies.
“Testing has revealed that Zebrafish embryos are highly
susceptible to toxins. In fact, Zebrafish labs are ubiquitous in most
universities and research hospitals,” said Steven Richter, PhD, president and
scientific director of Microtest Laboratories, and former US Food & Drug
Administration (FDA) official.
“We've confirmed the application of Zebrafish embryos in the
toxicity testing of materials used in medical devices,” Dr Richter said. “With
our in-vitro test, manufacturers and bio materials researchers can screen
thousands of polymers in less than a week — yielding significant economic
savings in both the time and expense of medical device testing.”
In its research, Microtest Laboratories found that the
current “gold standard” USP Cytotoxicity Assay, which utilizes live mouse
fibroblasts (L929) cells in culture, failed to detect the toxicity of a BPA
extract during testing — while Microtest's new Zebrafish embryo screen
succeeded.
BPA (bis-phenol A) is a suspected toxic polymer assumed as
having both carcinogenic and teratogenic effects on humans. The US Environmental
Protection Agency (EPA) has indicated that BPA will be slated for screening
soon.
“Microtest's new Zebrafish embryo assay has better
sensitivity and generates more scientific data than the small animal tests
currently recommended by the FDA,” Dr Richter said.
“The use of Zebrafish embryos will reduce or eliminate the
current animal testing required for all medical devices testing. This important
vertebrate model has demonstrated similarities to mammalian models and humans in
toxicity testing,” he noted.
Microtest Laboratories is a leader in medical device testing
and related services for the medical device, pharmaceutical, and biotechnology
industries.
http://www.pharmabiz.com/NewsDetails.aspx?aid=63858&sid=2
Madras High Court stays extension given
to DCGI until further orders
In a major embarrassment to the Government of India, the
Madras High Court has stayed until further orders the Union health ministry's
recent order in which it had given nine months extension to Dr Surinder Singh to
continue in the position of Drugs Control General of India (DCGI).
Hearing a public interest litigation (WP 15607/2011) filed by
T K Ramalingasamy, a former regulatory officer of the Tamil Nadu Drugs Control
Department, the High Court bench comprising chief justice M Y Iqbal and Justice
T S Sivanjaanam in its interim order made the extension given to Dr Surinder
Singh null and void till further orders.
On June 8, 2011 the Government of India had extended the
appointment of Dr Surinder Singh as DCGI until 31. 3. 2012. The DCGI’s
deputation tenure was to expire on June 21, this year.
According to Advocates from Sarvabhouman Associates who have
appeared before the court on behalf of the petitioner, the DCGI cannot continue
in his position until a further order from the court, and the government has to
give the charge to somebody else for the time being. Additional solicitor
general of India, M Ravindran has appeared in the court on behalf of the DCGI.
The advocate of the petitioner said that the case regarding
the appointment of the DCGI was pending with the court when the extension order
was issued. So the extension given by the government without the permission of
the court becomes sub judice.
The petitioner has argued in his petition that while
appointing Dr Surinder Singh as DCGI, the Government of India and the Union
Public Service commission had not followed all the provisions of Drugs &
Cosmetics Act and Rules. He prayed to the court to direct an inquiry into the
selection process of Dr Surinder Singh and pleaded for framing of rules for the
selection and appointment of candidates for the DCGI post.
On June 14, the Government of India issued a gazette
notification that the appointment of DCGI can be done through on deputation
basis. This was the mode of appointment the government followed at the time of
appointing Dr Surinder Singh.
http://www.pharmabiz.com/NewsDetails.aspx?aid=64048&sid=1
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