The US Food and Drug Administration has given organisations until 3 September to apply for grants to develop new animal drugs intended for minor species or minor uses in major species 1 ,2 . The grants, established under US legislation, could range ...
In order to quickly move forward on a war funding bill, the US Senate has dropped a number of amendments, including an amendment sent by the House of Representatives that pertained to a "pay-for-delay" ban 1 . Although pharma has gained a reprieve ...
Drug marketing authorisation holders have until 1 August to submit applications to the UK Medicines and Healthcare products Regulatory Agency to make any labelling changes that might be required for their products to remain in accordance with the ...
A non-governmental organisation has published guidance that it says will give companies a "head-start" in meeting the challenges of complying with the provisions of the UK Bribery Act, which comes into force in April 2011 1-3 . Transparency ...
Clinical trial inspectors from the US and the European Union are making strides in a joint inspections pilot programme they embarked on last year to identify how good clinical practice inspections can be conducted more effectively 1,2 . Joint ...
The US Food and Drug Administration plans to implement the next version of the electronic common technical document (eCTD) for regulatory submissions in 2013 and is urging stakeholders to get involved in its development programme. The regulated ...
The European Medicines Agency has published its new policy on communicating safety-related issues relating to human medicines 1 ,2 . It follows growing consensus on the need to improve communication on benefit:risk process outcomes and to enhance ...
The UK Bribery Act, which was signed into law earlier this year, will come into force in April 2011, the Ministry of Justice has announced 1 ,2 . Its implementation is expected to pave the way for fairer practice by encouraging companies to adopt ...
New legislation has been introduced in the US House of Representatives that would give mandatory product recall authority to the Food and Drug Administration 1 ,2 . The bill (HR 5740) was introduced by Edolphus Towns (Democrat ? New York), chairman ...
The European Commission has accused pharmaceutical company Servier of submitting "misleading and incorrect information" in response to a competition sector inquiry 1 ,2 . The commission has sent Servier a "statement of objections", claiming that it ...
China and Taiwan have signed a wide-ranging bilateral agreement on the protection of intellectual property rights, which lays down major principles with implications for many products, including pharmaceuticals 1 . The Cross-Strait Agreement on IPR ...
