Food & Drug Bulletin

Dear Reader:

As we enter into the 10th month of Dr. Henney's tenure as Commissioner of FDA, those of us involved in regulatory issues are still trying to read the tea leaves and discern the direction the agency will take under Henney's stewardship. One of the obvious changes will result from the resignation of two senior members of the agency, Bruce Burlington from CDRH and Dr. Freidman as a Deputy. Those who follow the agency will remember that William Schultz, also a Deputy, left shortly after Dr. Henney arrived. These changes in key positions suggest that Dr. Henney will be able to put her signature on the agency over the next year. Exactly what that signature will be in relationship to drug and device approvals, food matters other than safety, and regulatory compliance questions, is still unknown Ð although we have a few signals from Dr. Henney's speeches of her interest in particular activities.

While many people hope this will be a period of "management" where Dr. Henney spends her time trying to coordinate the agency's policies across Centers and streamlining issues related to food safety, drug approvals, biotechnology, etc., what I think we all recognize is that a change in Commissioners means a change in the status quo, and changes in senior staff mean that the status quo will change much more quickly than we had probably estimated. Hopefully, as a firm that is regulated by FDA or working in the FDA arena, you are enjoying this present time of what may be described as "calm."

Sincerely,

Gary L. Yingling

Articles In This Issue

FDA Releases Device Civil Money Penalty Policy Guidance

MDMA Petitions FDA to Ban Reprocessed Single Use Devices

Defendant Awarded Summary Judgment in High-Profile Proposition 65 Case

FDA Issues Revised Draft CPG on Destruction and Seizure of Publications that are Labeling

FDA Issues Y2K Compliance Policy Guide

FDA Issues OTC Sunscreen Drug Products Final Monograph

FDA Issues Proposed Rule Regarding Foreign Establishment Registration and Listing

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