10-Point Checklist
December 09, 2008
Are traditional software companies dinosaurs? How many of the top 100 firms on this list will be thriving in 2019? Their most dangerous rivals have moved online, using the web, following the path blazed by Salesforce.com. The buzzword is software as a service (SaaS).
Adobe, to take one example, said last week it is laying off 600…more...
A Quickening Process
December 01, 2008
The regulatory process in Brazil, previously seen as complicated and convoluted, just got simpler and more logical. The country has been a familiar destination for sponsors for at least a dozen years. It ranks up there with China, India and Russia. But Brazil’s regulatory structure has been slow, rigid, and some would say illogical by comparison.
In…more...
"No Doctor Left Behind"?
November 19, 2008
Editor’s note: A friend in Chicago knows someone. That someone was so concerned about this strongly-worded inter-office email from the Obama transition team that they passed it along. It does not represent the thinking of ClinPage, L.L.C. or its staff.
Hey Dawg,
“Mr. President-Elect” still sounds ... offffficial? Is there a policy on when we gotta be…more...
Silo vs. Life Cycle
November 10, 2008
In recent years, the industry has made massive investments in how it gathers data. Electronic data capture (EDC) and patient diaries have pushed growing amounts of data into digital formats.
But what of the other end of the process—where such data emerge for regulatory purposes? To an unfortunate degree, even the best data collection systems can become…more...
FDA Needs IT
October 27, 2008
Like the industry it regulates, the FDA finds itself in a slowly closing vise—squeezed between a mission that never seems to get much narrower and a budget that never gets much bigger. So we were interested to hear the comments of Douglas Throckmorton, deputy director in the FDA’s office of the director at the Center for Drug…more...
100 Languages Spoken Here
October 13, 2008
In the end, clinical development comes down to biostatistics and words—words in the protocol, the study report, the regulatory filings, the drug label. In a global world, getting those words right can be no small matter.
“There are a lot of translation companies out there. Only a handful specifically specialize in life sciences and health care,” says…more...
Coast: Ethics & Efficiency
August 29, 2008
As a clinical research assistant (CRA) in the 1990s, Darren McDaniel didn’t like what he saw when it came to institutional review boards (IRBs). From what he witnessed, sponsors had two choices: go with a slow, bureaucratic university- or hospital-based IRB, which typically convened once a month and tore protocols to shreds. Or go with a commercial…more...
Rejecting Schering's Sugammadex
August 06, 2008
A while back, we checked in with someone who makes a living suing the pharmaceutical industry. This week, we worked the other side of the street, chatting with Mark Mansour of Bryan Cave, where he runs the FDA practice group in the firm’s Washington, D.C. office.
Mansour has been perplexed, he reports, at the non-approvable letter that…more...
January 8, 2009
Rejecting Schering's Sugammadex
Mark Mansour of the Bryan Cave law firm says the FDA is on hold while America selects a president.
FDA, EMEA Milestone
Arizona’s Critical Path Institute gets industry, FDA and EMEA to agree on seven renal biomarkers.
'Absolutely overwhelming'
FDA’s Sandy Kweder painted a portrait of an agency straining to deliver on the many elements of FDAAA.
New FDAAA Paperwork
The FDA’s new Form 3674 is an attestation that a trial has been registered in clinicaltrials.gov.
REMS Risks
At Outcome’s Post-Approval Summit at Harvard, CDER head Janet Woodcock walked the audience through what FDAAA means.
Webinar: Tessella, United Biosource
Two leading firms, Tessella and United Biosource, discuss the perception that regulators are trying to slow down the adoption of adaptive designs.
