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.
Giant Eagle awarded for green efforts
PITTSBURGH Giant Eagle has received four awards from the Environmental Protection Agency for its eco-friendly practices and sustainability efforts, the supermarket retailer said.
Giant Eagle was the recipient of the EPA Montreal Protocol award, the GreenChill environmental award, the GreenChill building certification and the EPA Smartway transport partnership perfect performance score.
“Our multiple partnerships with the EPA are a significant piece of our overall sustainability strategy, which also includes our energy management efforts and recycling initiatives,” said Shelly Sponholz, Giant Eagle SVP real estate and development. “We truly believe that our environmental commitment is a vital part to the success of both our communities and our business, as so many of the sustainable projects we undertake produce tangible benefits to each.”
Giant Eagle operates stores throughout western Pennsylvania, Ohio, north central West Virginia and Maryland.
Retailers urge Congress to reject Chinese currency legislation
ARLINGTON, Va. As members of Congress move to try and force China to revalue its currency, the renminbi yuan, retailers are weighing in on the issue.
The Retail Industry Leaders Association, which represents more than 200 retailers, manufacturers and suppliers, asked lawmakers Friday to reject legislation under consideration Friday morning by the House Ways and Means Committee that would pressure China on its currency by imposing tariffs on products imported from there.
Alarge share of consumer products sold in the United States are made in China, and in many cases are no longer made in the United States. Thus, placing tariffs on goods imported from China could force retailers to pass the costs onto consumers.
“Provoking tension with our trading partners doesn’t come without costs, and we should choose our battles carefully, especially given the great amount of uncertainty in markets at this time,” RILA VP international trade Stephanie Lester said. “It makes little sense to enact harmful policies that will spark a bilateral conflict over currency with one of our largest trading partners and fastest-growing markets for American exports, given almost stagnant economic growth.”