FDA BOMB THREAT RESPONSE GUIDELINES, PREVIEW OF SECURITY ENHANCEMENTS at the agency's Parklawn Building in Rockville, Md. were issued in a memo dated Aug. 7. FDA is tightening security at the building in the wake of two recent bomb scares telephoned in to Parklawn employees that caused the building to be evacuated and searched. The heightened security measures also bring Parklawn "into compliance with the Department of Justice guidelines mandated by President Clinton." Security consultant reviews of FDA's outbuildings "will begin soon."
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.
