The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

A post-inspection letter from the US Food and Drug Administration raising concerns about a pharmaceutical company?s facilities may be unwelcome, but it could also be seen as an opportunity, according to one expert. Though form FDA 483 letters ...

Cécile Derycke and Agnès Roman-Amat discuss the implications of a Civil Supreme Court decision on ?defects? and ?causal relationships?. The French Civil Supreme Court (Cour de Cassation) has upheld for the first time a court of appeal judgment ...

A petition challenging a US federal appeals court?s test criteria for what types of inventions are considered ?patentable processes? has drawn considerable support from the life sciences industry 1 ,2 . Companies represented by the Biotechnology ...

As the European Medicines Agency celebrates the 15th anniversary of its creation in January 1995, its Committee on Advanced Therapies has marked its first year of operations by reviewing progress in developing the European Union regulatory framework ...

The Human Fertilisation and Embryology Act 2008 came into force in the UK on 1 October 1 ,2 . The law ensures that all human embryos outside the body ? whatever process used in their creation ? are subject to regulation, said the Department of ...

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 ...

The Irish Medicines Board is reviewing the suitability of existing methods of supplying veterinary anthelmintics and antiparasitic medicines intended for use in companion animals 1 . The IMB notes that the fact that there are various ways in which ...

The US Food and Drug Administration has issued a final rule defining what constitutes a ?small number of animals? under the Minor Use and Minor Species Animal Health Act. The MUMS act offers incentives to pharma companies wanting to develop drugs ...