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An FDA advisory committee may have voted against recommending approval of sanofi-aventis’ antibiotic Ketek if the agency had not withheld its concerns about clinical trial fraud from the members, Sen. Chuck Grassley (R-Iowa) said.
The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
The FDA sent warning letters to five firms for compounding topical anesthetic creams, but the firms say their manufacturing practices are beyond the FDA’s jurisdiction.
OTC drugs in very small “convenience-size” packages could qualify for “optional alternative labeling” under a proposed amendment to the FDA’s 1999 final rule on standardized format and content requirements for OTC drug labeling in general.
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s choice to
be the FDA commissioner was successful as the Senate voted overwhelmingly last week to approve the nomination. But the agency’s main critic, who attempted to block a vote on the nomination, remains determined to hold the FDA’s feet to the fire during the next session.
OTC drugs in very small “convenience-size” packages could qualify for “optional alternative labeling” under a proposed amendment to the FDA’s 1999 final rule on standardized format and content requirements for OTC drug labeling in general.
Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, and one of the agency’s more public faces, is going back to the private sector in January, the agency announced.
The FDA introduced changes to its regulations to make experimental drugs more available to seriously ill patients who have exhausted other treatment options.