Neglected Diseases – FDA Review Vouchers – a new source of revenue
Filed in regulatory, January 26, 2009, 2:47 pmIn September 2008 the FDA launched a new federal programme designed to increase the amount of work being undertaken in certain neglected tropical infectious diseases. (implemented by the FDA amendments act of 2007). This programme will award a sponsor of a drug for a tropical disease a voucher entitling the company an expedited review for [...]
Data Exclusivity Extends Market Protection to 11 years without a patent being required
Filed in regulatory, January 19, 2009, 10:41 amData exclusivity is an important tool in the area of pharmaceuticals and biological therapies, when you successfully apply for a product license in many European countries. This period of data exclusivity was originally implemented to cover areas where patent protection was limited. When a generic application is made for an existing drug, the pre-clinical and [...]
New FDA review rules, new EMEA & FDA paediatric rules and new EMEA safety rules are going to torpedo your development project and knock a large amount of the value out for your IP if your not ready!
Filed in regulatory, January 13, 2009, 9:40 amWe have the course that will ensure your well prepared, and at only £500 its great value.
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FDA: At the end of 2007, the USA government announced a wide ranging and disruptive review of the FDA mandate. It affects most element of what the FDA do and consequently what is required of [...]
Conditional Approval – An important short cut to the market
Filed in regulatory, January 6, 2009, 10:45 amUsually this data is not sufficient to award a full approval, but is of such a positive nature and the drug of such obvious benefit to a group with high unmet medical need that they will allow it to go to market whilst the clinical data is strengthened.
