Hi Marty,
The FDA has plans to make the process more efficient.
FDA Announces New Procedures to Speed Drug Development Supported by Research From the Tufts Center for the Study of Drug Development
PHILADELPHIA--(BW HealthWire)--Jan. 27, 1999--The U.S. Food and Drug Administration (FDA) today outlined its new procedures aimed at helping make the development of new drugs more efficient without sacrificing critical efficacy and safety data.
Speaking at a meeting hosted by the Tufts Center for the Study of Drug Development, Deputy Director of the FDA's Center for Drug Evaluation and Research, Murray Lumpkin, described a more formal approach to holding meetings between the FDA and pharmaceutical companies during the drug development process to resolve development and regulatory questions.
Requests for FDA/Sponsor meetings, as they are called, will now be assigned one of three priority rankings, depending upon their urgency. When assigned the top classification, a company request for a meeting with the FDA will be held within 30 days of the request. Previously, the hundreds of such meetings FDA has with sponsors each year to resolve questions relating to development of new medicines were held on an as-needed basis without explicit deadlines.
''The work done by the Tufts Center demonstrates that FDA/Sponsor meetings have a direct impact on the efficiency with which new drugs are developed,'' Lumpkin said. ''It is therefore all the more imperative that this process be managed as well as possible. We believe our new procedures will do this and will help fulfill the agreements reached in association with the reauthorization of the new drug user fee program by Congress.''
The new procedures are expected to help make new drug development programs more efficient and of higher quality. This should enable new medicines to get to patients more quickly, and are expected to receive a warm response from the pharmaceutical industry.
Max W. Talbott, Vice President of Worldwide Regulatory Affairs at Rhone-Poulenc Rorer, commented, ''This is good news for us and, ultimately, for consumers. It will make the development and approval process more efficient while ensuring continued adherence to the high standards which have been a hallmark of the pharmaceutical industry and the FDA.''
Kenneth I. Kaitin, Director of the Tufts Center for the Study of Drug Development, said, ''We found that the numbers and kinds of FDA/Sponsor meetings held can lead to significant reductions in the time needed to get new drugs to market. Before now no one had examined the impact of these meetings on the development and approval process.''
Based in Boston, Mass., and affiliated with Tufts University, the Tufts Center for the Study of Drug Development (www.tufts.edu/med/research/csdd) provides independent research on the development, regulation, and utilization of new drugs and biopharmaceuticals. Among other activities, it sponsors public forums where government, industry, academia, and public health advocates can exchange views on drug and biotechnology product development and regulation.
PS: Thanks for the link...
Jeffrey |
