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October 6, 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 is proposing a massive cut to its Office of Women’s Health (OWH), and Ruth Merkatz—director of the office from its inception to 1996—is flaming mad. “This is very unfortunate; we just hate to see the books being balanced on the backs of women’s health,” said Merkatz, adding that… more...
The world of FDA submissions is about to change. As the FDA announced last fall, several 1999 guidances were withdrawn. And as of January 2008, electronically submitted new drug applications will have to be submitted using the electronic common technical document (eCTD) format. “Since that news came out, we’ve experienced… more...
Qumas announced a new suite, and said it was priced at “half” of what the leading competition costs. It’s 21 CFR Part 11 compliant and has a minimal IT footprint, according to the company. Qumas serves the compliance software needs of the life sciences and financial services. It’s trying to… more...
The nonprofit Signatures and Authentication for Everyone (SAFE)-BioPharma Association certified a trio of Adobe products. The software complies with the SAFE digital signature standard. These are the first software products ever certified by SAFE, a non-profit association that manages digital identity and signature standards for pharmaceutical industries. Here’s a quote… more...
Octagon Research has announced its ability to interoperate with an electronic FDA system managing regulatory filings. Octagon has fulfilled the technical requirements to send electronic submissions to the FDA’s Electronic Submission Gateway (ESG) in a production environment. The ESG registration process requires transmission of compliant test data. Preparations and testing… more...
While most readers were enjoying the Super Bowl, we were contemplating something infinitely more interesting. To wit: this transcript of a recent PBS interview with FDA commissioner Andrew von Eschenbach. As we noted last week, the FDA has advanced a plan to deflect Congressional legislation that could, among other things,… more...
FDA has released a plan for enhancing drug safety. To pay for it, the agency has proposed a 29 percent rise in spending for a renewal of the Prescription Drug User Fee Act (PDUFA), from $304 million to $393 million. By definition, of course, such fees would be charged to… more...
Federal rules governing clinical trials—they’re a little important. That doesn’t mean you get a pass on state law, which covers the licensure of every health care professional involved in every trial. John Serio has just revised his own tome on the topic, The State-by-State Clinical Trial Requirements Reference Guide 2007.… more...
Target Health, out of New York, is the prototypical e-CRO, a contract research organization that is serious about developing its own software. Target e*CRF is an electronic data capture and project management tool that uses the internet. Jules Mitchel presides over Target Health with a cheerful exuberance undimmed by long… more...
The FDA proposed two new sets of rules for all patients to gain access to experimental drugs being evaluated in clinical trials. The proposals are the first to be announced under full-fledged FDA commissioner Andrew von Eschenbach, just this week formally confirmed to head the agency by the Senate. “Expanded… more...
