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Witnesses at a Senate hearing debated the costs and risks of allowing imported pharmaceuticals, with some saying a proposed bill would cause “a flood” of dangerous counterfeit drugs into the country and others claiming it would improve safety.
Organizations representing more than 60,000 pharmacists sent a letter to three senators discouraging them from introducing a bill that would strengthen federal regulations on compounded drugs.
As the debate over how the FDA should approve follow-on biologics continues, lawmakers acknowledged more work is needed to satisfy certain patient safety and interchangeability concerns raised by the pharmaceutical industry.
Witnesses at a Senate hearing debated the costs and risks of allowing imported pharmaceuticals, with some saying a proposed bill would cause “a flood” of dangerous counterfeit drugs into the country and others claiming it would improve safety.
The Senate Committee on Commerce, Science and Transportation is holding a hearing today on importing pharmaceuticals after lawmakers reintroduced a bill that would allow U.S. citizens to order drugs from FDA-approved Canadian pharmacies.
FDA staff say the Critical Path Initiative (CPI) is in trouble, with insufficient funding leaving employees working on the program during their off hours.
The authors of the legislation that paved the way for improved market access for generic drug firms are confident that legislation to facilitate biogeneric entry is likely to move forward before the end of 2007.
AdvaMed has reached an agreement with the FDA on user fees through negotiations on the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).
As Capitol Hill contemplates proposed legislation to establish approval mechanisms and analytical processes at the FDA to facilitate biogeneric entry, biotech firms are urging federal lawmakers to reject assertions in two highly publicized studies that claim follow-on biologics would save billions in healthcare costs.