Solicitation: FDA-RFI-1219078
The Food and Drug Administration seeks to establish a Blanket Purchase Agreement (BPA) or Indefinite Delivery/Indefinite Quantity (IDIQ) for professional services in support to new drug review modernization requirements.
The overall objectives sought through this acquisition include:
- Ensure IT designs enable the review process to function effectively across multiple CDER-wide stakeholders;
- Apply IT industry best practices to improve OND web and software applications in support of the new drug review process;
- Ensure regulatory compliance and standards include transparent and effective methods for the delivery of OND-wide services and products;
- Acquire writing and editing expertise, both editorial and scientific in nature, to streamline the drug regulatory review processes;
- Support comprehensive, standardized clinical safety analyses. Improve the dissemination and communication of cross-cutting health policy priorities…
The scope encompasses a range of professional services activities necessary to support the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) in nine (9) areas: (1) IT Enhancement and Support, (2) Medical and Scientific Writing & Editing, (3) Clinical Safety Data Analysis, (4) Health Policy Support, (5) Training, (6) Communications, (7) Meeting Support, (8) Program Operations Support and (9) Project Management services, to be applied across all tasks.
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