FDA Regulatory Agenda for 2009 Matches Forecast by Cerulean Associates LLC

Williamsburg, VA, March 02, 2009 --(PR.com)-- Documents released by the US Food and Drug Administration (FDA) last week laid out a schedule of regulatory guidance and agency expectations largely mirroring those forecast in December's SmarterCompliance newsletter.

Cerulean Associates LLC publishes the monthly SmarterCompliance newsletter, subscribed to by pharmaceutical, device and biotech executives around the world, and issues an annual forecast for the upcoming year between November and December.

"Last year," said Managing Director, John Avellanet, "our forecast gave over 40 recommendations for 2009, most of them just summaries of our more in-depth analyses we publish throughout the year in the newsletter. We’re really starting to see subscriptions take off as executives realize the business implications of getting a good 12 to 18 month lead on their competitors and the inspectors."

The December SmarterCompliance forecast that the FDA would release a revised version of 21 CFR Part 11, a Good Importer Guidance, Process Validation advice, and more guidance documents supporting the implementation of various aspects of Quality by Design throughout the lifecycle – from preclinical to postmarket – of drugs and biologics. The FDA's agenda as published by the Center for Drug Evaluation Research (CDER) specifies just those items. To help executives who have not had a chance to evaluate SmarterCompliance, Cerulean has made the first half of its December issue available for free download.

"Currently," said Mr. Avellanet, "we're turning our attention to the new drug and biologic pipeline implications of personalized medicines; so far we've published dozens of recommendations for our readers along with approximate timelines of marketplace adoption and regulatory rulings."

"Let's not kid ourselves," cautioned Mr. Avellanet. "Our February 2008 prediction that some sort of regulatory pathway for follow-on biologics would be in place by the end of this year [2009] may or may not come to pass. The initial budget from the new administration supports such a move, but a whole lot of maneuvering has to go on before a generic biologics pathway exists."

Cerulean's SmarterCompliance newsletter mixes compliance and regulatory intelligence with specific recommendations, strategies and quality systems tactics executive teams can adopt. Cerulean surveys a broad set of information sources, including the FDA's own publications, warning letters, daily news, other governmental publications, blogs, and so on to synthesize the information that is then analyzed for subtexts, trends and themes.

Journalists who would like a complimentary subscription to Cerulean's SmarterCompliance newsletter can contact Mr. Avellanet directly through the Cerulean website.

Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at www.ceruleanllc.com.

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