In the middle of the fiscal year, the FDA is proposing an immediate $1.2 million cut to its Office of Women’s Health, for which Congress had already set aside $4 million. Why? Some speculate that it’s payback for the emergency-contraceptives controversy. more...

A tool to create, manage and view both documents and processes in the regulatory environment. more...

A new tool for regulatory submissions and everything that touches them. more...

Adobe wins more traction for the PDF format in pharma. more...

In 2008, electronic submissions to FDA will have to be in the eCTD format. Says Octagon Research’s Nancy Smerkanich: “Companies need to prepare. It’s not something you turn a switch on and do overnight.” more...

PBS interviews the new FDA commissioner, who does fine. PBS doesn’t do so well. more...

The agency says $29 million of $87 million in proposed new spending would go toward 80 additional employees to monitor drug safety in the post-marketing arena. more...

A reference guide by lawyers John Serio and Dorothy Puzio goes well beyond clinical trial research involving prisoners and residents of mental hospitals. The authors say that state law is likely to be especially important in the event that something goes awry. more...

Target Health, a technology-oriented contract research organization, has a new web-based program for document management in regulated industries. It’s called Target Document. more...

Two proposed rules will allow patients to receive unapproved drugs under “expanded access” rules. Among other conditions, an experimental drug will have to be used in the treatment of an “immediately life-threatening disease.” more...

CDISC, FDA and industry have formed a diverse body to address data in adaptive trials. Anthony Costello of Nextrials will be the representative of the Society for Clinical Data Management (SCDM). more...

Company wins CRO business for tracking regulatory workflow and global quality. more...

Qumas maintains blogs for both life sciences and financial services customers, and has a white paper with general information about regulatory systems. more...

On December 18, the FDA will hold a hearing on submission data to the FDA. But there are signs that the FDA is thinking beyond submissions. more...

In an online presentation, the consulting arm of invivodata, the Pittsburgh ediary firm, channels FDA thinking on making sure electronic diaries are as rigorously designed as paper equivalents. more...

In an otherworldly deal with prosecutors, the former head of FDA plead guilty to making false statements and concealing ownership in companies his agency was regulating. Lester Crawford will be sentenced in January. more...