EMA & FDA
EMA & FDA 21/12/2009
EMEA expects 2010 fee revenues to rise 12%
The European Medicines Agency says it expects to receive fee revenues worth 152.78 billion euros in 2010, compared to just under 141 billion euros this year.
EMA & FDA 07/12/2009
EMEA to present Road Map 2015 this week
The proposed new initiative is a continuation of the 2010 Road Map, building on current achievements but also taking account of the Agency’s business drivers, and has as its draft title The Agency’s Contribution to Science, Medicines and Health.
EMA & FDA 30/11/2009
New visual identity, web/e-mail addresses and organisation chart of the European Medicines Agency
Communication to all Agency partners, stakeholders and the public.
EMA & FDA 26/11/2009
European Medicines Agency publishes a detailed report on the geographic distribution of patient recruitment in clinical trials
Тhe Agency has been actively tracking the geographic origins of patients included in pivotal trials submitted in marketing authorisation applications to the centralised procedure.
EMA & FDA 28/10/2009
Industry years behind on testing approved drugs
Federal drug officials have long been criticized for failing to force drug makers to complete studies proving that their drugs work as hoped, and Congressional investigators on Monday released yet another report pointing out that some of these studies remain undone many years after being promised.
EMA & FDA 08/10/2009
FDA marks 100th HIV/AIDS drug authorized for purchase under PEPFAR
To date, more than 100 products have been assessed by the FDA and either fully or tentatively approved in association with the PEPFAR program.
EMA & FDA 06/10/2009
EMEA reorganizes, moves transparency agenda forward
The European Medicines Agency (EMEA) announced yesterday that it has begun a series of changes to its internal organisation, aimed at improving its functioning and how it delivers its core tasks to be introduced gradually by year-end.
EMA & FDA 05/09/2009
FDA review on postmarketing studies for approved drugs and biologics
FDA study indicates most industry postmarketing studies meet timelines.
EMA & FDA 22/08/2009
Physicians lack knowledge of off-label drug use and FDA approval status
In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief could encourage them to prescribe these drugs, despite the lack of scientific evidence supporting such use.
EMA & FDA 13/08/2009
FDA expands access to investigational drugs
FDA announced changes to the rules to make them broader and clearer for the patient and the treating physician, while still preserving the integrity of clinical trials designed to find out whether a drug has a desired effect on some disease or condition.
EMA & FDA 13/08/2009
What a drug label doesn't tell you -- but should
The Food and Drug Administration requires a lot of detailed information on the labels that come with prescription drugs. But labels don't provide doctors and patients with information on how the medication compares to other drugs.
EMA & FDA 15/07/2009
FDA issues draft guidance on drug anticounterfeiting
The U.S. Food and Drug Administration has issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.
EMA & FDA 30/06/2009
Groups urge US FDA to release info on rejected drugs
The U.S. Food and Drug Administration should make more information available to the public, even on drugs and devices that never make it to the U.S. market, consumer advocates told the health agency on Wednesday.
EMA & FDA 27/06/2009
Seven years’ protection sufficient for brand biologics, says White House
Seven years’ exclusivity “strikes the appropriate balance between innovation and competition.”
EMA & FDA 23/06/2009
EMEA seeks public opinion on new transparency policy
The European Medicines Agency has kicked off a period of public consultation on its brand new policy on transparency, which is designed to foster “a robust and consistent approach” throughout the group’s operations.
EMA & FDA 03/06/2009
US public to have “a seat at FDA table”
The US Food and Drug Administration (FDA) has set up a task force to help it become more open and accountable to the public.
EMA & FDA 29/05/2009
FDA is reviewing Ranbaxy’s corrective plan on drugs to the U.S.
The U.S. drug regulator is reviewing a “corrective action” plan from India’s Ranbaxy Laboratories Ltd. after some medicines from its plants in the South Asian nation were barred from being exported to the U.S.
EMA & FDA 28/05/2009
FDA issues guidance on presenting drug risks on TV ads
US regulators have issued guidelines to drugmakers about the way they should present risk information for the treatments when advertising on television or in journals.
EMA & FDA 25/03/2009
Support growing for moves to split US FDA
US drug industry leaders are reported to be privately supporting proposals to split the Food and Drug Administration (FDA) into two separate agencies, one with responsibility for food issues and the other dealing with drugs and medical products.
EMA & FDA 20/03/2009
New US biogenerics bill offers 14 years’ market exclusivity
Legislation introduced this week in the US Congress would give innovative biological drugs 14 years’ market exclusivity before generic versions could come onto the market.
More...
