We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA's Chicago district office and the Society of Clinical Research Associates are sponsoring a workshop on FDA clinical trial statutory and regulatory requirements May 16-17 in Oak Brook, Ill.
Sponsors wishing to test new high-risk drugs for the first time in human subjects are advised to conduct additional preliminary studies in some circumstances under a new draft guideline from the European Medicines Agency (EMEA).
Drugmakers spent $155 million lobbying Congress between January 2005 and June 2006, trying to influence legislation on Medicare, drug importation and patent protection, according to a study by The Center for Public Integrity.
Canadian drugs sold to consumers in the U.S. via the internet last year were half what they were the year before, according to IMS Health researchers who blamed a variety of market factors for the dramatic plunge in sales volume.
The European Medicines Agency (EMEA) recommended adding a warning for patients and doctors about Roche's flu drug Tamiflu after the agency learned of new reports of neuropsychiatric adverse events occurring with the use of Tamiflu in Japan.
Two leading House lawmakers are investigating FDA Commissioner Andrew von Eschenbach's recent testimony on Ketek over concerns that he may have "intentionally misled" a subcommittee about the drug's approval process.
Amgen's clinical program to expand Vectibix's use as a first- and second-line treatment for metastatic colorectal cancer is not affected by the discontinuation of the Avastin-Vectibix combination trial, which was halted due to efficacy and safety concerns.
The Centers for Disease Control and Prevention (CDC) is recommending routine Gardasil vaccines for girls females 1126 to prevent certain strains of the human papillomavirus (HPV), Merck announced.
After pressure from Congress, federal investigators will reopen 103 cases of potential conflicts of interest among NIH employees, according to HHS Inspector General Daniel Levinson.