I. Introduction

II. Announcing Agency Intentions and Expectations ... A. The FDA’s Struggles in Promulgating Regulations … B. Guidance-making as the New Rulemaking ... 1. Evolution of the FDA’s Good Guidance Practices ... 2. Congressional Demands for FDA Guidance ... 3. Extending GGPs to Other Agencies? ... C. Too Much of a Good Thing at the FDA?

III. Securing Adherence to Announced (and Unannounced) Policies ... A. Threats/Offers in the Enforcement Context ... B. Offers/Threats in the Licensing Context

IV. Conclusion