A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...

The US Food and Drug Administration is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications 1 . The programmes, designed for reviewers at the FDA?s Center ...

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

A new guidance on developing human cells for clinical applications is available 1 . The guidance was issued by the British Standards Institution , which says the document was written with an EU/US audience in mind and anticipates that it will be ...

The US Food and Drug Administration has expressed concern over the protracted negotiations it is having with the medtech industry over reauthorising its medical device user fee programme, minutes from a 2 August meeting between the FDA and industry ...

The US Food and Drug Administration is introducing two new training programmes to improve the consistency and skill of its medical device unit staff who review pre-market applications 1 . The programmes, designed for reviewers at the FDA?s Center ...

The Danish Medicines Agency has issued a list clarifying which clinical trial amendments will require approval by the DMA and which modifications can merely be notified to the agency 1 ,2 . The list has been issued in response to questions on the ...

The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems 1 . Implementing UDIs in ...

The US Senate Judiciary Committee has approved a bipartisan bill to limit pay-for-delay settlements that the bill's supporters say will keep lower-cost generic drugs off the market 1 ,2 .  The Preserve Access to Affordable Generic Drugs Act, which ...

Ravimiamet, Estonia's drug regulatory agency, has intensified its oversight of television advertisements for medicinal products, after finding that all advertisements televised on three TV channels in June failed to comply fully with the legal ...

Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...

A Supreme Court judge set to hear a case involving a challenge by Novartis against Section 3d, a controversial provision in India's patent law, has recused himself ? a move that is now expected to require a new judge to hear the case at a later date ...

The US Senate Judiciary Committee has approved a bipartisan bill to limit pay-for-delay settlements that the bill's supporters say will keep lower-cost generic drugs off the market 1 ,2 .  The Preserve Access to Affordable Generic Drugs Act, which ...

The governments of New Zealand and Australia have agreed on a new trans-Tasman plan to implement a single patent application and examination process for both countries that would provide inventors with a faster, cheaper and more streamlined patent ...