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The FDA’s much-touted Critical Path Initiative to expedite the drug development process has been delayed as other issues, including safety concerns about marketed drugs, have drawn the agency’s attention.
The FDA has released a compliance policy guidance to assist pharmaceutical manufacturers with the implementation of radio-frequency identification (RFID) feasibility studies and pilot programs to strengthen the U.S. drug supply chain and to promote the widespread use of RFID technology by 2007.
Pfizer will add radio-frequency identification (RFID) tags to all packages of Viagra sold in the U.S. by the end of 2005 to protect patients against the risk of ingesting counterfeit versions of the drug. Other manufacturers plan to follow Pfizer’s lead.
Janssen Pharmaceutica has selected ABB to install a Part 11-compliant manufacturing system in its new greenfield active pharmaceutical ingredient (API) plant in Cork, Ireland.
By some measures, as many as 80 percent of clinical trials are delayed by three months or more because of difficulties in finding patients for the studies, according to experts who tout internet and online database recruiting as possible solutions to the problem.
The public's growing desire for cosmetic improvements combined with increasing numbers of dental professionals practicing implant techniques is expected to boost revenues in the U.S. dental implant market 250 percent by 2008, according to a new study released by the Millennium Research Group (MRG).
Pfizer has announced it will add radio-frequency identification (RFID) tags to all packages of Viagra sold in the U.S. by the end of next year to protect patients against the risk of ingesting counterfeit versions of the drug.
Pharmaceutical manufacturers could reap benefits of $500 million to $1 billion annually by implementing electronic product code/radio frequency identification (EPC/RFID) technology, while healthcare distributors could see benefits of $200 million to $400 million per year, according to a report from the Healthcare Distribution Management Association (HDMA) Healthcare Foundation.
While President Bush indicated that he is open to the possibility of importing drugs from Canada if such a plan could be proven safe, Democratic presidential candidate Sen. John Kerry (D-Mass.) retorted that the president has blocked legislation that would do just that.