New Risk Management Landscape For Drugs Offers Fertile Ground For CROs
The coming year could see the first use of the enhanced safety powers created by the FDA Amendments Act, but 2008 is certain to see a shift in the pharmaceutical industry's development approach as it grapples with the need for more safety data
You may also be interested in...
FDA is bringing in outside consultants to help improve staff interactions and build leadership in the agency's Center for Drug Evaluation and Research
Final FDA reform legislation that cleared Congress adds an additional $225 million to industry's user fee tab over five years, but limits penalties that FDA can assess to enforce its new authorities to mandate labeling changes and postmarket studies
The rate of delayed postmarketing commitments has increased since 2005, according to data provided in FDA's annual "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies.