These topics were tagged with "EMA & FDA"
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24/10/2012 - European Medicines Agency starts infringement procedure to investigate Roche’s alleged non-compliance with pharmacovigilance obligations
So far, there is no indication of a negative impact on the benefit-risk balance of the medicines affected; For the time being all medicines remain authorised without changes to the treatment advice fo... -
17/10/2012 - EU auditors report on EMA conflict-of-interest record
The European Medicines Agency (EMA) is doing better than some other European Union (EU) agencies in terms of dealing with conflict of interest issues, but there is still room for improvement, accordin... -
02/10/2012 - FDA meeting to kick off patient-focused development debate
“Patients who live with a disease have a direct stake in the outcome of the review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur throughou... -
26/09/2012 - FDA gets new authority over clinical trial reporting
The US Department of Health & Human Services has transferred authority to the FDA to oversee information that is filed with ClinicalTrials.gov. Here is an interesting development in the ongoing contro... -
11/09/2012 - For those of you who follow FDA doings…
Organizational changes can often have a significant impact on how decisions are made. Watching the FDA may seem like so much ‘inside baseball’ to the vast majority of people, but organizational ch... -
05/09/2012 - Is the FDA sacrificing safety for speed?
In its quest to speed approvals and reward innovation, is the FDA greenlighting medicines with too many risks? An essay in the Journal of the American Medical Association argues that the agency may, i... -
16/08/2012 - European Medicines Agency explains EU incident management plan for human medicines
This plan explains how the European Medicines Agency, the European Commission and medicines regulatory authorities in the EU Member States work together to ensure that the most appropriate actions are... -
20/07/2012 - European Medicines Agency publishes video explaining pharmacovigilance legislation
The new pharmacovigilance legislation came into operation on 2 July 2012. The European Medicines Agency has produced a video with an introduction to the new pharmacovigilance legislation. Watch Dr Pet... -
17/07/2012 - EMA to make clinical trial data available
Clinical data no longer deemed commercially confidential. After being harshly criticized for refusing to release clinical trial data, the European Medicines Agency plans to hold a conference in Novemb... -
21/06/2012 - EMA: Roche failed to report lots of side effects
The European Medicines Agency is investigating whether Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths. The probe come... -
07/06/2012 - EU Ombudsman raps EMA in child medicines case
The European Ombudsman has called on the European Medicines Agency (EMA) to increase the transparency of its procedures for ensuring that children can benefit from new medicines. In October 2009, Astr... -
31/05/2012 - European Medicines Agency boosts EU transparency with online publication of suspected side effect reports
Member States and the Agency release data on medicines in compliance with EudraVigilance access policy. The European Medicines Agency has today begun publishing suspected side effect reports for medic... -
17/05/2012 - FDA reviews drugs quite quickly, thank you
The FDA is approximately two months faster than the other two key agencies – the European Medicines Agency and Health Canada – in issuing approvals. A key point in the debate over renewing the Pr... -
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. Next time you... -
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. May 3, 2012 — A ... -
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 read... -
25/04/2012 - Stifling new cures: The true cost of lengthy clinical drug trials
Project FDA report. Read the document here. ... -
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. Continually on the defensive about its efforts to monitor drug safety, the FDA issued a... -
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. The U.S. Food and Drug Administra... -
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. The European Medicine... -
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. The Food and Drug Administration (... -
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. European regulators will no longer consider trials whose protocol was not first submitted to an indep... -
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. The officials fr... -
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... -
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. With all the talk of reforming the FDA - speeding approvals... -
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. Recognising the “dramatic changes” in the global ... -
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. Four years ago, the Food a... -
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 o... -
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. The EMA will publ... -
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...
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