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October 7, 2008
New FDAAA Paperwork
New FDA Form 3674, Explained
The FDA’s new Form 3674 is an attestation that a trial has been registered in clinicaltrials.gov.
REMS Risks
FDA’s Woodcock On FDAAA
At Outcome’s Post-Approval Summit at Harvard, CDER head Janet Woodcock walked the audience through what FDAAA means.
Webinar: Tessella, United Biosource
Adaptive Designs: The Regulatory Issues
Two leading firms, Tessella and United Biosource, discuss the perception that regulators are trying to slow down the adoption of adaptive designs.
Tech Preview: Clinical Tablet
PHT Device Aimed At Sites
The patient-reported outcome company moves its software to a Samsung device with a new form factor and operating system.
Profile: Phlexglobal
Mastering The Trial Master File
More global locations and outsourcing can make for a messy process to generate a trial master file (TMF). Phlexglobal bundles services and software to help.
The FDA and CDISC selected a member of the clinical trial vendor community to a new data standards committee. Anthony Costello is a co-founder of Nextrials, a California electronic data capture (EDC) company. It’s not clear whether other members of the CDASH committee are yet to be nominated, or are… more...
Sparta Systems announced that Icon, a contract research organization, has selected Sparta’s TrackWise. The system is an enterprise tool for managing global quality requirements that focuses on internal, external, and supplier audits, as well as Corrective and Preventive Action (CAPA) management. TrackWise is a 21 CFR Part 11 compliant, web-based… more...
As most readers know, Qumas is a company specializing in software for heavily regulated industries. Its tools ensure organizational compliance with both documents and processes. In a press release, Qumas, the leading developer of enterprise governance, risk and compliance solutions, today announced it has been named Company of the Year… more...
On December 18, the FDA will hold a hearing on submission data to the FDA. The agency announced the meeting on November 16, 2006. But there are signs that the FDA is thinking beyond submissions and quite broadly about a variety of e-clinical data. Here’s a quote: “The Food and… more...
How does the FDA want sponsors to handle patient-reported outcome data? That question is looming over every company that ponders whether a paper diary or some other approach is warranted. PHT offered a webinar on patient reported outcomes (PRO) just a few weeks ago that we regret to have missed.… more...
Lester Crawford, former head of the FDA, plead guilty to making false statements and concealing ownership in companies his agency was regulating. A judge will sentence Crawford in January. His punishment could include prison time or probation and a fine. “I want to accept full responsibility for my errors and… more...
Mark Senak is a lawyer and works at the public relations firm Fleishman-Hillard. This week, Senak’s Eye On FDA blog tallies up members of FDA advisory committees without online CVs. Why are some committees posting all their members’ biographies, and others only doing so sporadically? It’s an excellent point. Senak… more...
Earlier this week, the FDA heard two expert views on nanotechnology. The number of products the FDA has already approved using nanotechnology? Nine, including Abraxane, Acticoat and Estrasorb. The prepared remarks made at the FDA are online. The blog nanotechwire brought this to our attention and has an interesting story… more...
How electronic should the offices of regulatory agencies be? On the one hand, they’re accustomed to paper. They have no legal mandate to require electronic submissions, only the ability to gently encourage the industry to move toward electronic systems. The FDA is certainly doing that. But as the FDA’s own… more...
We all do it. It makes no sense. It is ridiculous. Sending attachments to and fro, hither and yon. “Did you get my attachment?” “Did you read my document?” “Any thoughts?” “Um, which version of that is live?” This is how some people spend their days. Google has new free… more...
