pharmacovigilance news from FierceBiotech
News1,300 new hires planned for FDA expansion
The FDA is hiring some 1,300 badly-needed workers to help with drug Read more...
Millennium spent $1.3M on lobbying
According to public records, Millennium Pharmaceuticals spent $1.3 million in 2007 lobbying the federal government on patent reform and biotech drug regulation. A bill--currently in the Senate--had Read more...
In speech, Lilly CEO calls for drug monitoring
In a speech at the Cleveland Clinic, Eli Lilly chairman and CEO Sidney Taurel (photo) called for greater use of health IT in order to Read more...
FDA expert wants Avandia withdrawn
The FDA's David Graham says that GSK's Avandia should be pulled from the market due to safety concerns. The safety Read more...
CollaGenex touts Phase IV Oracea dataCollaGenex Pharmaceuticals says that a post-approval study of Oracea in combination with Galderma Laboratories' MetroGel skin treatment demonstrated a significant advantage over the MetroGel therapy combined with a placebo in clearing up rosacea. Volunteers taking the combined Oracea-MetroGel therapy experienced an average 66.4 percent reduction in skin inflammation compared to a 48.2 percent average for MetroGel combined with a placebo. After dropping MetroGel from the combinations, the … Read more...FDA seeks $87M in fees for drug safety work
The FDA is looking for Congressional approval to assess more than $87 million in new drug company fees so it can hire up a new group of regulators to help manage the agency's post-approval Read more...
FDA, drug industry re-negotiate user feesThe pharmaceutical industry is in the process of negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the FDA, as the current agreement is due to expire at the end of 2007. The biggest proposed change would be for drug companies to pay additional fees that would be used to fund post-marketing drug safety studies. "Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on … Read more...New push on for FDA reform legislationSenator Ted Kennedy is set to ratchet up the pressure for FDA reform at a Senate hearing today. The move is aimed at pushing reform legislation that would mandate new post-approval studies as well as give the agency more authority to update drug labels. Lawmakers are also likely to hear plenty of calls for new funding support for the FDA. - here's an article on … Read more...Editor's Corner
IOM slams FDA, calls for major reformsIn a long-awaited review, the Institute of Medicine has slammed the FDA, saying its drug safety monitoring systems are inadequate and in need of reform, hampered by bad management and subject to incessant internal disputes. A spokesperson at the FDA said that the agency had made significant progress over the two years since the Vioxx debacle rattled the agency, but also recognized that more work was needed. The report outlines a series of suggested changes that would dramatically … Read more... | Press ReleasesPRESS RELEASE: Adverse Drug Events Reported to FDA Appear to Have Increased Markedly ADVERSE DRUG EVENTS REPORTED TO FDA APPEAR TO HAVE INCREASED MARKEDLY CHICAGO—The number of serious adverse drug events reported to the U.S. Food and Drug Administration (FDA) more than doubled Read more... PRESS RELEASE: University of Miami Miller School of Medicine and Humana Launch Drug Safety Surveillance Program University of Miami Miller School of Medicine and Humana Launch Drug Safety Surveillance Program MIAMI -- The University of Miami Miller School of Medicine and Humana Inc. today Read more... |
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