FDA’s Drug Review Process and the Package Label, (PDF) guidance to pharmaceutical companies for writing FDA-submissions, such as the BLA, NDA, Clinical Study Reports, and Investigator’s Brochures. The ebook provides guidance to medical writers for drafting FDA-submissions in a way more likely to encourage FDA reviewers to grant approval of
This updated Stroke: Pathophysiology, Diagnosis, and Management, 6th edition (PDF) delivers convenient access to the latest research findings and management approaches for cerebrovascular disease. Picking up from where J. P. Mohr and colleagues left off, a new team of editors — Drs. Grotta, Broderick, Albers, Lo, Mendelow, Kasner, Sacco, and Wong
Rereading America: Cultural Contexts for Critical Thinking and Writing 9th edition (PDF) remains the most widely adopted ebook of its kind because of its unique approach to the issue of cultural diversity. Unlike other multicultural composition readers that settle for representing the plurality of American cultures and voices, Rereading America
Remediation Engineering: Design Concepts 2nd Edition (PDF) has evolved and advanced from the stage of being a sub-discipline of environmental engineering into its own engineering discipline supporting the growth of a global industry. This fully-updated 2nd edition will capture the fundamental advancements that have taken place during the last 20
Leadership and Literacy: Principals, Partnerships and Pathways to Improvement (PDF) emphasizes on what school leaders need to know and comprehend about leadership for learning, and for learning to read in particular. It brings together research, theory and practice on leadership for literacy. The ebook reports on the findings from six