« Return to News | Ethics/Regulatory

FDA holds J&J under magnifying glass

Friday, January 13, 2012 01:34 PM

The FDA has trained a watchful eye on Johnson & Johnson as delayed reports, recalls and court trials pile up.

“I think the FDA, now that it has its eyes on J&J, is taking a look at everything," Les Funtleyder, analyst with Miller Tabak, told the Star-Ledger. "There's no question, the FDA is getting more stringent.”

The FDA posted a letter on its web site Jan. 10 warning J&J that it could face fines and injunctions if the company’s Animas unit, which failed to report malfunctioning insulin pumps, does not detail within 15 days how it will improve the problems, according to the Star-Ledger.

Companies are required to report malfunctions within 30 days, but in two cases Animas waited several months to inform the FDA that patients using the company’s pumps had to be hospitalized, according to a Star-Ledger report.

The FDA has reprimanded J&J for several other quality control issues in the past two years, according to the Star-Ledger. Although one plant has resumed shipping, the central plant of a massive recall remains shut down.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.