EMA & FDA
EMA & FDA 10/05/2012
Drug labels often lack pediatric information
A new study by FDA staffers found that only 231 medicines of 461 listed in the Physicians Desk Reference had adequate information that doctors would need to prescribe a drug to children.
EMA & FDA 04/05/2012
FDA must be proactive about postapproval drug safety: IOM
FDA to make postmarketing research of drugs' risks and benefits a priority and to develop a centralized system for managing all information about drugs throughout their life cycles.
EMA & FDA 25/04/2012
Stifling new cures: The true cost of lengthy clinical drug trials
Project FDA report.
EMA & FDA 25/04/2012
Many pediatric studies remain unpublished
"One of the most important obligations to the children and families who have willingly enrolled in trials is to ensure that their participation can benefit all children. Only timely, complete and readily available clinical trial results can meet this obligation."
EMA & FDA 24/04/2012
FDA: We’re tough on post-marketing safety
FDA issued a report that trumpets various undertakings to oversee medicines after they have reached the market.
EMA & FDA 21/04/2012
Three big HIV days in May at the FDA
The U.S. Food and Drug Administration has three important advisory committees planned in May to review new strategies in prevention, treatment and diagnostic testing.
EMA & FDA 20/04/2012
EMA finalises guidance on third-country trial standards
Third-country trials included in EU regulatory filings should meet equivalent ethical principles and standards to those applied when studies are carried out in the member states.
EMA & FDA 18/04/2012
FDA considers overdose antidote for over-the-counter use
The Food and Drug Administration is considering whether to allow non-prescription use of naloxone (Narcan), which can prevent opioid overdose from heroin or Vicodin.
EMA & FDA 17/04/2012
Stricter rules on trials used in European marketing applications
Clinical trials used to support European marketing applications will face stricter rules from May.
EMA & FDA 12/04/2012
European regulators back access to raw trial data – with caveats
It is “neither desirable nor realistic to maintain the status quo” of clinical trial data being available on a limited basis, a group of leading European drug regulators believes.
EMA & FDA 29/03/2012
EMA plans 239.1M-euro 2013 budget; Parliament "no" to 2010's spending
The Management Board of the European Medicines Agency (EMA) has this week adopted a preliminary draft budget for 2013 of 239.1 million euros, but the European Parliament has refused to approve how the Agency spent its budget for 2010.
EMA & FDA 15/03/2012
FDA swayed by politics & industry: FDA scientists
A new survey finds that most agency scientists believe political and corporate influence have sizeable weight on final regulatory decisions.
EMA & FDA 14/03/2012
FDA hearing seeks input on modernising clinical trial framework
Gathering views on whether and how it can do more to modernise and streamline its approach to regulation and Good Clinical Practice in the field.
EMA & FDA 05/03/2012
FDA: Drugmakers & their post-marketing commitments
FDA is authorized to require drugmakers to conduct and report on postmarketing studies to assess known serious risks, safety signals or identify an unexpected serious risk.
EMA & FDA 25/02/2012
Will Rasi peel back the curtain on the EMA?
The agency, which was set up in 1995 and is 80% funded by industry fees, has been criticised in the past for not providing enough access to clinical data for drug researchers and for being secretive over its decision making processes for medicines.
EMA & FDA 22/02/2012
EMA to publish ongoing drug evaluation info from March 1
From March 1, the European Medicines Agency (EMA) will start to publish information on applications for centralised marketing authorisation (MA) which it has received for evaluation.
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.
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