The US Food and Drug Administration has sent warning letters to 13 molecular diagnostic companies as part of its bid to improve the regulation of genetic testing 1 . The agency has targeted firms selling genetic tests directly to consumers, ...

The US Food and Drug Administration has sent warning letters to 13 molecular diagnostic companies as part of its bid to improve the regulation of genetic testing 1 . The agency has targeted firms selling genetic tests directly to consumers, ...

The European Commission's public consultation on proposed revisions to the In Vitro Diagnostics Directive (98/79/EC) contains a section on "conditional CE marking" that has caught the attention of European medtech industry association Eucomed 1 . ...

The European Commission has launched a formal public consultation on proposed revisions to the In Vitro Diagnostics Directive 1 . Stakeholders have until 15 September to submit feedback. The commission had last week indicated plans to launch such a ...

The US Food and Drug Administration has issued final guidance to help manufacturers develop and conduct studies for in vitro diagnostic devices to support their pre-market submissions 1 ,2 . The guidance contains recommendations for studies to ...

The European Commission will launch in the “coming days” a public consultation on the revision of the in vitro diagnostic directive (Directive 98/79/EC) that will invite comments from stakeholders by 19 September 1 ,2 . A formal proposal to revise ...

Sharon Williams discusses the regulatory hurdles for IVDs. The in vitro diagnostics industry represents one of the most lucrative segments in the global healthcare industry 1 . The global IVD market has been growing at a rate of 5-6% in recent years ...

The Human Tissues Working Party of UK charity the Safer Medicines Trust believes that individuals on the organ donor register should be asked about the possibility of donating tissues that would be removed solely for use in research (ie not for ...

There will be a delay in the appointment of the new executive director at the European Medicines Agency , the European Commission has confirmed to RAJ Devices 1 . A commission spokesperson said: "It is now certain that there will be an interregnum ...

A somatic cell therapy for treating cardiovascular diseases has become the first product to obtain certification of experimental data by the European Medicines Agency under the European Union´s framework for advanced therapy medicinal products 1 ,2 ...

The European Medicines Agency’s Committee for Advanced Therapies is drafting guidance to explain how medical device notified bodies should interact with the EMA when evaluating advanced therapy medical products containing a medical device. European ...

The Committee for Advanced Therapies at the European Medicines Agency has officially adopted and published its reflection paper on in vitro culture chondrocyte containing products for cartilage repair of the knee 1 . The paper, which contains ...

Representatives from several European life sciences industry associations, including medtech group Eucomed, will meet with the European Medicines Agency’s Committee for Advanced Therapies later this month. The meeting, due to take place on 11-12 May ...

The Irish Medicines Board , having found no takers for a new service it started last year to offer formal scientific advice on the drug component of drug/device combination products, is planning to charge a reduced fee for the job 1 ,2 . Reacting to ...

Health Canada has decided to put on hold a new product licensing requirement under which manufacturers of medical devices with a drug component were required to provide the Drug Identification Number (DIN) of the product’s medicinal component to ...

The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to address the issue 1 . In addition to requiring ...

The European Commission has formally adopted a new procedure that will allow small and medium-sized enterprises to use a new procedure for certifying their early quality and nonclinical data on advanced therapy medicinal products 1 ,2 . The ...