Always ask FDA to show ID
Executive SummaryFDA warns consumers Nov. 12 about "a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as FDA Special Agents" or other agency officials. FDA said calls entice consumers to purchase discounted drugs by wiring funds to addresses in the Dominican Republic. A follow-up call attempts to blackmail the consumer, insisting that a fine of several thousand dollars be sent to the DR to avoid incarceration or other legal action. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business," said Michael Chappell, acting associate commissioner for regulatory affairs, in the press release
You may also be interested in...
ConMed's CFO Todd Garner told delegates at the Jefferies Healthcare conference that the company's orthopedic franchise is focused on its pipeline and meeting customer's needs. See what the CFO said about it here.
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.
Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.