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 ...
Maureen Kenny reports on efforts by the European Medicines Agency to ensure manufacturers of advanced therapies won't be caught out by approaching approval deadlines. At least 20 advanced therapy medicinal products that are currently on the market ...
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 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 ...
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 ...
