EMA & FDA
EMA & FDA 20/01/2012
EU agency issues guideline on biosimilar MS drugs
European regulators took another step towards opening the market for copies of biotech drugs by releasing a draft guideline on how companies should test biosimilar medicines containing interferon beta, used to treat multiple sclerosis.
EMA & FDA 28/12/2011
FDA issues off-label information guidelines for industry
The guidelines will permit drug and device makers to provide information on off-label uses, but only if the request for information is unsolicited. An unsolicited request is one not initiated in any form by the drug or device maker or distributor itself.
EMA & FDA 22/12/2011
FDA lacks authority to prevent rising number of drug shortages, report says
Pharmaceutical companies should be required to notify the U.S. Food and Drug Administration of situations that may lead to drug shortages, thereby allowing the agency to address production issues and enhance product availability.
EMA & FDA 19/12/2011
EMA expecting 10% more scientific advice requests in 2012
The European Medicines Agency (EMA) says it is expecting requests for scientific advice from makers of human-use medicines to increase 10% next year.
EMA & FDA 16/12/2011
European Medicines Agency to continue to involve patients in scientific discussions on human medicines
The inclusion of the patient viewpoint enriches the overall evaluation of the benefits and risks of medicines.
EMA & FDA 05/11/2011
FDA says drugs approved in U.S. before Europe
Americans in the past year got access to 24 new medicines before they became available anywhere else, U.S. drug regulators said as they seek to show they are doing enough to promote medical innovation.
EMA & FDA 04/10/2011
FDA still trying to become more transparent
Finding additional ways to organize and present information that so many people have difficulty finding on the FDA website.
EMA & FDA 22/09/2011
WHO’s ICTRP portal to incorporate EU Clinical Trials Register
The European Union Clinical Trials Register (EU-CTR) has been recognised as one of the primary registries for the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP).
EMA & FDA 04/09/2011
FDA urges remote monitoring of clinical trials
FDA wants to encourage sponsors to undertake more of what the agency calls risk-based monitoring in order to match international standards articulated by the International Conference on Harmonisation.
EMA & FDA 04/09/2011
FDA may get two more months to review new drugs
U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs.
EMA & FDA 31/08/2011
US FDA urged to change rules on generic drug risks
The US Food and Drug Administration (FDA) has been urged to revise its rules to allow generic drugmakers to update their product labeling to warn patients about risks associated with their drugs.
EMA & FDA 05/08/2011
2011's US new drug approvals "already match 2010's total"
"The industry has to reverse a long-term decline in R&D productivity. And the FDA has to find a way to ensure the safety of new drugs while not slowing the introduction of new and needed therapies or creating undue burdens for developers."
EMA & FDA 05/08/2011
FDA guidance on investigator financial disclosures needs more work, says WLF
Proposals from the US Food and Drug Administration to strengthen requirements for financial disclosure by clinical investigators in cases where conflicts of interest may arise need to show more clarity, transparency and sensitivity to privacy rights, argues the Washington Legal Foundation.
EMA & FDA 16/07/2011
European Medicines Agency plans public access to information on side effects
The European Medicines Agency has published its plans for granting public access to the information held in its databases of the potential side effects of human and veterinary medicines.
EMA & FDA 14/07/2011
EMA seeks input on genomic markers in drug development
The European Medicines Agency (EMA) has put out for consultation a reflection paper on the use of pharmacogenomic biomarkers as patient selection and treatment stratification tools in drug development.
EMA & FDA 05/07/2011
FDA "must be made an independent agency," says biotech
The US Food and Drug Administration (FDA) must be made an independent agency with a clear mandate to encourage the development of innovative products, industry leaders have urged.
EMA & FDA 21/06/2011
FDA sets out plans to keep closer eye on imports quality
The US Food and Drug Administration has unveiled a "new global strategy" to manage the number of products it has approved which are then imported.
EMA & FDA 03/06/2011
Study provides recommendations on European Medicines Agency's communication on medicines
A report written by an independent expert has highlighted a number of recommendations to help improve the European Medicines Agency's communication on the benefits and risks of medicines.
EMA & FDA 03/06/2011
European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent
Public consultation open until 1 September 2011.
EMA & FDA 26/05/2011
Information overload in drug side effect labeling
The lists of potential side effects that accompany prescription drugs have ballooned in size, averaging 70 reactions per drug, a number that can overwhelm physicians trying to select suitable treatments for their patients.
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