Umen & Co. - Strategic Regulatory Consulting and Medical Writing for Pharma and Biotech


		An NDA is the Only “Form” of a Drug That Most Regulators Will Ever See. A Firm Should Look at its NDA as an Example of its Finest Work.

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template by Mary Vanderhoof, MS Michael J. Umen, PhD David N. Schwartz, BS As printed in Drug Information Journal, Vol. 42, pp. 349-357, 2008.

	Read Full Article (requires Adobe Reader)

Both the guidance documents issued by FDA to industry and the guidance documents intended to be used internally by FDA’s own staff of medical review officers (MROs) can be effective tools to help sponsors prepare their regulatory submissions. Two recent reviewer guidance documents, the clinical review template and the corresponding guidance, “Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review,” provide useful insight into the FDA review process. The review of the clinical data has always been on the critical path to market approval for new molecular entities, and the recent reauthorization of the Prescription Drug User Fee Act (PDUFA IV) has underscored both the importance of an efficient review and postmarketing safety monitoring. The more FDA and the sponsors harmonize their efforts, with sponsors providing the summaries and analyses (including comprehensive tables, figures, and listings) that MROs need to adequately assess the safety data and document their reviews, the greater the opportunity for FDA to meet the performance goals set out in PDUFA and for FDA and industry together to deliver safe and effective new therapies to US patients in a timely fashion.

Six Enduring Principals for Preparing NDAs by Michael J. Umen, Ph.D. As printed in Drug Information Journal, Vol. 34, pp. 703-707,2000.

	Read Full Article (requires Adobe Reader)

Six enduring principles for preparing New Drug Applications (NDAs) are advanced: Principle Number 1: An NDA is the document that supports the labeling of a drug, Principle Number 2: An NDA is the only “form” of a drug that most regulators will ever see. A firm should look at its NDA as an example of its finest work, Principle Number 3: NDAs are organized to facilitate review by the authorities, Principle Number 4: Group studies in a logical order, Principle Number 5: Standardization of format and consistency of content make for high quality applications, and Principle Number 6: Getting it submitted on time is important; but getting it right is more important if your goal is an approved application.

Winning Plays in the R&D Game
by Robert W. Keidel Ph.D. and Michael J. Umen, Ph.D.
As printed in the Pharmaceutical Executive, February 1984.

Are my medicinal chemists playing baseball but being managed like a football team? Are my new-drug application (NDA) teams playing baseball instead of basketball? These may appear to be strange questions for pharmaceutical executives to ask themselves? However, such questions can be relevant and may provide powerful insights to help managers score points in the industry. Omit the sports terms, and they become questions pharmaceutical executives frequently ask themselves....

Download Full Article
(requires Adobe Reader)