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Takeda’s television reminder ad for sleep agent Rozerem suggests that the product is indicated for use in children, making the it subject to the regulations of standard director-to-consumer advertising, according to a March 5 FDA warning letter.
The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year.
The intercenter agreements (ICAs) governing how combination and single-entity products are assigned to U.S. FDA centers have become “incomplete statements” due to a slew of emerging products and the volume of jurisdictional decisions the agency has made in recent years, the FDA said.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) have asked FDA Commissioner Andrew von Eschenbach to respond to an independent review that called the agency’s postmarketing surveillance system “dysfunctional.”
The U.S. Food and Drug Administration’s (FDA) proposal to regulate complex genetic laboratory-developed tests (LDTs) could stifle the development and marketing of new diagnostics, presenters said at a recent public meeting.
A U.S. Food and Drug Administration (FDA) program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, a new report concluded.
Because several U.S. Food and Drug Administration (FDA) centers and various regulations are involved with combination products, whatever is happening with them will have an impact on all other products, Mason Diamond, vice president of clinical and regulatory affairs for TyRx Pharma, said at a recent audioconference sponsored by the Regulatory Affairs Professionals Society.
The FDA has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.
Former FDA Commissioner Lester Crawford will have to pay $90,000 in penalties and serve three years of probation for federal fraud charges levied against him for failing to disclose financial conflicts of interest and making false statements, his attorney said.