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Device manufacturers must tap the right number of subject matter experts (SMEs) when developing the company’s standard operating procedures (SOPs), according to an industry executive who warned this decision can be the hardest part of implementing an SOP.
The Association of Medical Device Reprocessors (AMDR) opposes legislation introduced in Massachusetts that would require hospitals to notify patients and get their consent before fitting them with reprocessed devices.
California voters overwhelmingly rejected two proposals Nov. 8 that would have reduced drug costs by either instituting a voluntary price-reduction program or by forcing companies to lower prices by threatening to pull their products from the state’s Medicaid program.
California voters overwhelmingly rejected two proposals Nov. 8 that would have reduced drug costs by either instituting a voluntary program or by forcing companies to lower prices by threatening to pull their products from the state’s Medicaid program.
Andrx plans to meet with the FDA around Thanksgiving to discuss manufacturing violations that have stalled approval of its drug applications. The company, which requested the meeting, said the FDA has not yet commented on any of its responses to the inspectional observations.
The FDA has scheduled two public events to discuss current medical device regulations and future legislation to update the 2002 Medical Device User Fee and Modernization Act.
The FDA has been meeting some fiscal 2005 performance goals established under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), but it is unclear whether the agency will reach all of those targets because only limited measurable data is available, according to a new report from the Government Accountability Office (GAO).
Although an increasing number of generic drugmakers appear willing to participate in the authorized generics market, the controversial practice may soon face increased scrutiny from the FTC, according to an industry expert.
Public interest groups are concerned that an FDA initiative to use risk-based reviews to speed drug approvals could cause more problems than it solves.