April 25, 2019Safety

Nonsense About Ketek

Ex-PPD Employee Testifies

Allegations of fraud, but no connection to the larger safety questions about Ketek. more...

Agency Yields To Critics

FDA Limits Ketek Usage

After studying a controversial antibiotic for more than a year, the FDA changed its label. more...

'Sentinel,' Other Tools Planned

FDA Outlines Major Safety Overhaul

The announcement by the FDA is an ambitious, major effort to reassure the public without explicitly committing the agency to yet another layer of regulation or any specific, lasting changes to how drug safety is reviewed after drugs are brought to market. more...

Rethinking Everything

Drug Safety Landscape Shifts

The comments from Relsys were made before the recent FDA announcement about drug safety. more...

Otsuka, Solvay, Pfizer Make Switch

Relsys Wins 6 Clients

The company names six new clients. more...

Funds for IT, post-marketing, safety

FDA: Raise PDUFA Fees 29 Percent

The agency says $29 million of $87 million in proposed new spending would go toward 80 additional employees to monitor drug safety in the post-marketing arena. more...

11 New Contracts

Sentrx Doubles Client Roster

The New Jersey drug safety firm posts a banner year. more...


The peer-reviewed journal PLoS Clinical Trials has a fascinating exchange of letters relating to drug safety, IRBs, DSMBs and public perceptions of clinical trial governance. A Cleveland Clinic broadside against the NIH. more...

Tech Demo: DataTrak eClinical

New Suite Transcends Integration

DataTrak International is a leader in electronic data capture (EDC), but its eClinical suite offering has broadened to the point where the vendor could threaten several larger rivals, including those offering clinical trial management and interactive voice response (IVR) systems. more...

New $500M Lilly Pact?

Drug Safety Beyond The FDA

Lilly will settle 18,000 Zyprexa lawsuits for $500 million. In the present climate of high visibility for drug safety, modern systems to correctly anticipate drug safety signals will be paramount. The third “Key Theme” from ClinPage in 2007. more...

Phase Forward Touts Reports, Safety

Using InForm In Academia

Academics at Dana-Farber are just as keen as industry to combine electronic data capture and drug safety tools. Phase Forward’s InForm software can also use the hospital’s patient registration system to populate fields of demographic data needed in the trial. more...

Off-label promotion for dementia?

NYT: Lilly Hides Obesity Data on Zyprexa

The drug company denies any misconduct and hopes the controversy will go away. more...


A physician-scientist will help transfer best pharmacovigilance practices from Montreal to Europe. more...

Utterly Pointless

EMEA Launches New Database

EMEA Executive Director Thomas Lönngren said: “Once fully developed, this database will be the reference point for independent information about all medicines available to Europeans, no matter whether these medicines have been authorised at EU or national level.” more...

Article in 'The Scientist'

FDA Worried About Congress

An article in The Scientist suggests that details of a new drug safety environment are being worked out behind the scenes. more...

Biotech fights back

Amgen: Critics In Error

Amgen says it is trying to rebut physician rumors and gossip about the safety of its blockbuster, Epogen. more...

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