PAREXEL ANNOUNCES ALL-NEW EDITION OF NEW DRUG DEVELOPMENT: A REGULATORY OVERVIEW
BOSTON, MA, October 19, 2000 — PAREXEL International Corporation has just released an all-new and expanded edition of New Drug Development: A Regulatory Overview, what PAREXEL believes to be the most widely read reference on the U.S. drug development and regulatory process.
Now the largest and most comprehensive reference of its kind ever compiled, the 500-page New Drug Development: A Regulatory Overview provides readers with detailed analyses and insights on each and every stage of the drug development and regulatory process, from preclinical testing through postmarketing studies.
The just-released text also provides useful insights on the developments that have shaped, and those that are about to fundamentally reshape, the evolution of the pharmaceutical development and regulatory process in the United States. New Drug Development: A Regulatory Overview analyzes how such factors as the ICH’s common technical document (CTD), the fast track approval program, the pediatric studies initiative, and the emergence of “risk management” concepts in drug reviews are affecting both the FDA and the pharmaceutical industry.
Now in its fifth edition, New Drug Development: A Regulatory Overview has become what PAREXEL believes to be the most widely read and most respected textbook chronicling the new drug development and regulation process in the United States since its initial release in 1987.
New Drug Development: A Regulatory Overview is available for $145 (plus $10 shipping/handling in North America, or $15 elsewhere) from PAREXEL International, 900 Chelmsford St., Lowell, MA 01851. To order or for more information on this text, call 800-937-7795 (in U.S.) or 978-275-0062, fax 978-275-4263, or visit www.parexel.com.
PAREXEL is one of the largest contract pharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. With a commitment to providing solutions that accelerate time-to-market and peak market penetration, PAREXEL has developed significant expertise in clinical trials management, data management, biostatistical analysis, medical marketing, clinical pharmacology, regulatory and medical consulting, industry training and publishing and other drug development consulting services. The Company’s integrated services, therapeutic area depth and sophisticated information technology, along with its experience in global drug development and product launch services, represent key competitive strengths. Headquartered near Boston, MA, PAREXEL operates in 43 locations throughout 29 countries around the world, and has approximately 4,200 employees.
This release may contain "forward-looking" statements regarding future results and events, including statements regarding expected financial results, future growth and customer demand that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes”, “anticipates”, “plans”, “expects”, “intends”, and similar expressions are intended to identify forward-looking statements. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: the cancellation, revision, or delay of contracts, including those contracts in backlog; the Company's dependence on certain industries and clients; the Company's ability to manage growth and its ability to attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; government regulation of certain industries and clients; competition and consolidation within the pharmaceutical industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations. These factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Annual Report on Form 10-K for the period ended June 30, 2000.