EMEA about to open doors to Advanced Therapy product applications
The European Medicines Agency (the EMEA) is readying itself to deal with Advanced Therapy Medicinal Products as of the beginning of next year.

Monday 5 January 2009

US FDA updates guidance on PMA supplements
The US FDA publishes a guidance document on December 11 that advises industry on the regulatory pathway to take when companies modify class III devices that are subject to premarket approval (PMA).
Wednesday 17 December 2008

Portugal opens a door to passer-by AED use
Portugal is to set up a national network of automatic external defibrillators (AEDs), backed by legislation allowing non-medical, passer-by use of the device in public areas, subject to licensing arrangements. The plans, which hinge on the principle that external defibrillation is a medical activity, are set out in draft legislation, now out for public consultation.
Thursday 11 December 2008

"Don't do anything radical with medtech regulations!" European Commission told
The overall message to the European Commission from medical device sector stakeholders is that the current EU medtech regulatory system is proportionate and appropriate for the products it regulates and should not be subject to radical changes.
Tuesday 9 December 2008

UK and EU nanotech policy "based on ignorance and uncertainty"
The UK's Royal Commission on Environmental Pollution (RCEP) has slammed national policy on nanotechnology as being founded on "profound ignorance and uncertainty".
Tuesday 25 November 2008

US devices centre falls under scrutiny of Congress, "gross violations" alleged
An investigation has been launched into allegations that managers within the FDA’s Center for Devices and Radiological Health (CDRH) corrupted and interfered with the scientific review of medical devices.
Friday 21 November 2008

US FDA to open its first global offices in China
The US FDA is opening its first offices abroad - in China - this week.
Friday 21 November 2008

Taken aback at EC recast proposals, MHRA offers “proportionate” solution
The European Commission is “missing the target and not addressing the real issues” relating to the implementation of the medical device directives, says Steve Owen, the head of devices policy and European and regulatory affairs at the UK’s MHRA.
Thursday 13 November 2008

A growing medtech role in NHS copayment reforms?
UK plans unveiled yesterday to expand access to NHS treatments and to allow private treatment to run in parallel to NHS care, enabling patients to have an active role in embracing innovative – and potentially more costly – treatments, should increasingly impinge on access to innovative medical technology too.
Monday 10 November 2008

Cervical screening trumps vaccine plans, as Irish economy bites
Ireland is to prioritise the national roll-out of its CervicalCheck smear test programme, at the expense of introducing HPV vaccination.
Thursday 6 November 2008

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