Please login to the form below

Not currently logged in
Email:
Password:

FDA warns Pfizer over adverse reporting

The US FDA has issued Pfizer with a warning letter relating to failures to report adverse events correctly

The US Food and Drug Administration (FDA) has issued Pfizer with a warning letter relating to failures to report adverse events correctly.

The letter, sent to Pfizer on May 26, follows an inspection of the company's New York premises by the US agency, which took place over a period of several weeks almost a year ago.

The inspection was to check Pfizer's procedures for conforming to the FDA's rules that adverse events must be reported to the authority within 15 days.

The letter contained reference to several instances where the pharma giant did not report adverse events relating to Lipitor (atorvastatin calcium) and Lyrica (pregabalin) at all. Further issues included the failure to report issues of visual disturbances as a result of a patient taking Viagra (sildenafil citrate) within the specified 15 day time period.

The US regulator also accused Pfizer of downgrading the classification of some reported events without justification.

In April 2010, the FDA warned Pfizer over its Geodon trials.

10th June 2010

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Jet Off with Maloff Protect

Latest intelligence

brian smith science of the deal
The science of the deal
Business development is more like child-raising than you might think...
The other side of … rheumatoid arthritis
For Georgie, patient activation fuelled her motivation to find life without pain. So when blood tests came back normal, she felt confident to pursue referral until RA was confirmed......
How to lessen site burden with a targeted patient recruitment strategy
Picture this: you’ve created your patient recruitment strategy and you find more and more patients are undertaking the pre-screening, you probably think – success! But then you find out, getting...

Infographics