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In its Counterfeit Drug Task Force final report, the FDA recommended that manufacturers adopt electronic track-and-trace technology, as well as a number of other authentication technologies, in order to combat the distribution of counterfeit drugs.
Jamie Hintlian is a partner in Accenture’s Health & Life Sciences practice, involved with the company’s role as the group manager for a coalition of pharmaceutical manufacturers, distributors and retailers that has been set up to evaluate the potential of radio-frequency identification (RFID) technology for enhancing the safety and security of the pharmaceutical supply chain, improving the process of pharmaceutical returns management and increasing the efficiency of distribution operations.
Despite urging industry to adopt electronic track-and-trace technologies over the next three years as part of a campaign against counterfeit drugs, FDA officials acknowledge they don’t know what the ultimate cost of such a move will be and are relying on market forces to drive the potential price of compliance to reasonable levels.
Top executives at biotechnology companies said yesterday they expect little change at the FDA despite the decision by President Bush to nominate FDA Commissioner Mark McClellan to head the Centers for Medicare & Medicaid Services.
Generic firm Dr. Reddy’s yesterday said it had filed an application to market a bioequivalent version of Pfizer’s top-selling hypertension drug Norvasc (amlodipine besylate) — just two weeks after it reported the FDA had stayed final approval for Dr. Reddy’s slightly different version of the product.
The pharmaceutical industry’s interest in early-stage compounds for drugs in the pipeline may create new opportunities for biotechnology companies to supplement their research and development efforts, according to the participants in a panel discussion held at the BIO CEO & Investor Conference in New York City yesterday.