OR WAIT null SECS
Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
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.
February 02, 2003
Health experts are recognizing teh need to plan for global manufacturing of new treatments for AIDS and other diseases.
January 01, 2003
The establishment of a Medicare pharmacy benefit tops the to-do list of industry-related policy issues for 2003.
December 02, 2002
Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.
November 02, 2002
FDA is juggling momentous changes, including new leadership and the proposed transfer of oversight for therapeutic biotech drugs.