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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.

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Slashing FDA Department?

FDA Women’s Office Faces Cuts

March 12, 2007

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...

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Demo: Regulation Management System

ViewPoint From Octagon

February 15, 2007

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 As the FDA announced last fall, several 1999 guidances were withdrawn.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...

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Combining Content, Submissions

Qumas Debuts Compliance Suite

February 13, 2007

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...

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Signable PDFs

Adobe Wins SAFE Certification

February 13, 2007

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...

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The Coming Shift

Octagon’s Advice on eCTDs

February 09, 2007

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...

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New 18-Month Window

Eschenbach Talks Safety On PBS

February 05, 2007

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...

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Funds for IT, post-marketing, safety

FDA: Raise PDUFA Fees 29 Percent

January 15, 2007

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...

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Poland Here We Come

State Law: Why Local Rules Matter

December 20, 2006

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...

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Validated Collaboration System

New Document Management Tool

December 15, 2006

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...

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New Draft Guidance

FDA To Widen Access To Experimental Drugs

December 11, 2006

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...

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