EMA & FDA
EMA & FDA 25/11/2008
More women now in clinical trials: study
The proportion of women in clinical trials has become more representative, although there are still areas for improvement, according to research by the FDA.
EMA & FDA 24/11/2008
The US pays millions for unapproved drugs
Taxpayers have shelled out at least $200 million since 2004 for meds that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid.
EMA & FDA 19/11/2008
U.S. says food, drug inspection access in China improving
U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China.
EMA & FDA 15/11/2008
FDA vouchers for neglected diseases could be 'inefficient,' 'dangerous,' NEJM perspective piece says
A new FDA voucher program, which provides pharmaceutical companies that develop drugs for neglected tropical diseases with a "voucher" for accelerated FDA review of other drug applications, is an "inefficient and potentially dangerous way of encouraging research into tropical diseases".
EMA & FDA 30/10/2008
FDA grants tentative approval for 75th generic anti-retroviral drug
"As we grant tentative approval for the 75th product, our efforts won't stop: we will continue to provide review of applications for safe and effective treatments for AIDS to combat this global concern."
EMA & FDA 29/10/2008
FDA staff objected to preemption policy: report
Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.
EMA & FDA 29/10/2008
Drugs delayed in U.S. as regulators struggle with new duties
The Food and Drug Administration is missing target dates to act on new drug applications because the agency doesn't have enough staff to handle them after getting new duties from Congress a year ago, an FDA official said.
EMA & FDA 24/10/2008
Extensions of indication - Prezista, Pegasys
The CHMP gave positive opinions for applications for extension of indication.
EMA & FDA 23/10/2008
GAO critical of FDA’s overseas inspections
A report has been published detailing the US Food and Drug Administration’s failings in its inspection of overseas manufacturing facilities.
EMA & FDA 15/10/2008
EMEA activities “on target,” says interim report
The European Medicines Agency performed well during the first half of 2008, undertaking particularly high levels of activity in the provision of scientific advice and protocol assistance.
EMA & FDA 23/09/2008
Most failed clinical trials are never published
A review of 909 clinical trials for 90 meds approved by the FDA between 1998 and 2000 found that more than half of the studies concluding a drug was ineffective were never published in medical journals.
EMA & FDA 22/09/2008
House members send letter to Secretary of State Rice requesting information on antiretrovirals supplied to PEPFAR by Ranbaxy
FDA last week announced that it has banned imports of more than 30 generic drugs that were manufactured by Ranbaxy, citing manufacturing deficiencies at two of the company's plants.
EMA & FDA 18/09/2008
Citing safety concerns, FDA bans imports of Ranbaxy drugs made in two Indian plants, including antiretrovirals
FDA announced that it has banned imports of more than 30 generic drugs, including antiretrovirals, manufactured by Indian generic drugmaker Ranbaxy, citing manufacturing deficiencies at two of the company's plants.
EMA & FDA 05/09/2008
Industry concern over EU hepatotoxicity guidance
Recent draft guidance highlights the challenges that industry and regulators face to predict rare drug-induced liver injury.
EMA & FDA 05/09/2008
FDA to post list of drugs with safety issues
In keeping with its new mandate to pay closer attention to safety, the agency will be compiling a quarterly table of drugs that have been identified as having some kind of potential safety issue.
EMA & FDA 03/09/2008
Drug monitoring in children led to recommendations on safety
One-third of the drugs scrutinized under a U.S. regulatory initiative to encourage testing of medicines in children needed action such as changes to prescribing information to warn of side effects, a study found.
EMA & FDA 26/08/2008
FDA issues new rules on product warning label updates for pharmaceuticals, medical devices
FDA last week issued new rules that aim to ensure medication warning labels provide clear and concise information to consumers.
EMA & FDA 06/08/2008
EMEA plans to test parallel imports
The European Medicines Agency is planning to include parallel-imported medicines in its annual Sampling and Testing Programme of centrally-authorised products.
EMA & FDA 18/07/2008
FDA rule and companion guidance make early stage clinical drug development safe and efficient
The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice statutes and FDA investigational requirements.
EMA & FDA 09/07/2008
FDA changing notices on drug decisions
U.S. regulators will change the way they tell drugmakers that their medicines are not ready to be approved.
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