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Massachusetts could become the first state to pass a law requiring licenses for pharmaceutical sales representatives, after the Massachusetts Senate passed the proposal as an amendment to the state budget May 25.
Clinical trial sponsors and research sites alike must know the rules for billing Medicare, Medicaid and private insurers for medical services provided to participants in clinical trials.
Biotech firms are in a race against the clock to get broad Sarbanes-Oxley (SOX) reforms before the next round of filings are due now that the SEC has denied industry’s request to exclude smaller companies from SOX reporting and auditing requirements, an industry source says.
The FDA has issued an International Conference on Harmonisation (ICH) guidance that could help drugmakers win "regulatory flexibility" that potentially includes fewer postapproval submissions and a reduction of end-product release testing.
The Centers for Medicare & Medicaid Services (CMS) will soon issue a regulation designed to ensure an accurate calculation of average manufacturer prices (AMPs) and will not post those prices by the required July 1 deadline, according to the head of the agency.
Establishing a pregnancy registry is an extremely useful way of gathering information on drugs effects in pregnant women — information that cannot be obtained through clinical trials, according to an expert speaking at an FDAnews audio conference.
Boston Scientific has warned that some defibrillators produced by its recently acquired subsidiary Guidant may suddenly stop working due to a battery malfunction, adding that it is working to make its postmarket surveillance of device performance more transparent.
The FDA has changed dramatically over the past year, becoming too cautious in its approval of new drugs due to a high-profile drug safety incident and a flood of congressional inquiries, a former agency official says.
Staffers at the FDA’s Center for Drug Evaluation and Research (CDER) who are planning medical research projects with human subjects now are required to observe the rules set forth in a new manual of policies and procedures (MAPP).