|
|
Article: FDA may create safe harbor for new products under PAT initiative. (Process analytical technology).
- Article from:
- Validation Times
- Article date:
- October 1, 2002
- Author:
CopyrightCOPYRIGHT 2002 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
BETHESDA, MD -- The Center for Drugs may exempt process analytical technology (PAT), from currently marketed drugs, but believes it should be applied during the research phase.
Ajaz Hussain, Ph.D., deputy director of CDER's Office of Pharmaceutical Science, told the Generic Pharmaceutical Assn. (GPhA) meeting here Oct. 16, that FDA is laying out a "safe harbor" for manufacturers willing to invest in PAT.
"There is a concern about this [PAT] not being a requirement," Hussain said. "It depends on business's needs--they ought to do this, not be required to do this."
In addition, he said, FDA hopes to lighten the regulatory burden on businesses by ...