GPhA and FDA to discuss me-too medicines at technical conference

WASHINGTON —More than a dozen top Food and Drug Administration officials will meet with generic drug industry leaders next month to discuss the latest regulatory and technical developments on the me-too medicine front, the Generic Pharmaceutical Association announced.

The GPhA/FDA 2010 Fall Technical Conference will kick off Oct. 19 at the Bethesda North Marriott Hotel and Conference Center in Maryland. On hand will be a slate of FDA officials, led by Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

Woodcock will deliver the keynote address. Also speaking at the three-day annual event will be Keith Webber, acting director of the FDA’s Office of Generic Drugs; Lawrence Yu, deputy director of science and chemistry for the agency’s generic division; and Ilisa Bernstein, a pharmacist and attorney who is acting deputy director of CDER’s Office of Compliance.

The list of scheduled speakers also includes Dale Conner and Barbara Davit, who head OGD bioequivalence activities.

“Last year, over 500 industry and FDA professionals attended this important, educational event,” the GPhA noted. “More than 150 staff members from the FDA’s Office of Generic Drugs joined their industry colleagues to share information and discuss issues that are critical to both industry and the FDA.”

A GPhA representative called the event “the premiere science and regulatory meeting for the generic pharmaceutical industry,” and added, “GPhA’s Fall Technical Conference is the only conference of its kind where attendees can hear presentations by OGD staff and meet them during the many networking opportunities.”

Among the topics that will be addressed are labeling issues for abbreviated new drug applications, chemistry manufacturing and controls, trends in drug compliance and supply chain security, and the 180-day market exclusivity awarded to first-approved ANDAs.

Networking opportunities, according to the GPhA, include two breakfasts, luncheons, morning and afternoon refreshment breaks, a reception and a buffet dinner and party on Oct. 20.