OR WAIT null SECS
November 02, 2003
FDA's new policies intend to make GMP inspections more efficient and apply to stricter rules to high-risk products and processes.
October 02, 2003
FDA offers new policies to encourage modern manufacturing approaches and automated systems, to simplify postapproval changes, and to avoid problems with sterile products.
September 02, 2003
FDA and manufacturers seek to curb drug counterfeiting while legislators consider liberalizing drug importing policies to cut pharmaceutical costs.
August 02, 2003
Manufacturers face challenges from FDA's plans to streamline the drug review and development processes aimed to spur innovation.
July 02, 2003
Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.
June 02, 2003
FDA's plan to establish pharmacogenomic policies spurs concerns among manufacturers, particularly in regard to how the policies will affect new-drug testing and approval.
May 02, 2003
FDA resolves the bar code labeling debate, releases its GMP requirements for dietary supplements, and proposes a comprehensive adverse-event reporting system.
May 01, 2003
Regular update from Washington.
April 02, 2003
FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.
March 02, 2003
Concerns about the safety and efficacy of dietary and herbal products are generating manufacturing requirements and analytical standards for ingredients.