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Following Hospira’s recall last month of sterile sodium bicarbonate injections, the FDA has extended the expiration dates for more than 90 lots to help alleviate a critical shortage of injectable drugs. Read More
PhRMA and AdvaMed expressed “grave concerns” about the FDA’s final rule clarifying when tobacco products are regulated as medical products, saying that the rule’s altered “intended use” definition is overbroad in its restriction of communications. Read More
The Senate Appropriations Committee unanimously approved a bill on Thursday that would provide a total of $5.2 billion for the FDA in fiscal 2018. Read More
The report recommends actions for the FDA and other federal agencies, as well as state and local governments and healthcare-related organizations. Read More
The European Commission issued a Statement of Objections to Teva over its 2005 “pay-for-delay” deal with Cephalon in which Teva agreed not to market a cheaper generic for Cephalon’s sleep disorder drug Provigil (modafinil). Read More
Takeda’s patent for its multiple myeloma drug Velcade was restored and extended for five more years after a federal appeals court overturned a district court ruling. Read More
The court ruled an Actavis product would infringe on Lilly’s patent for the Alimta vitamin regimen regardless of the diluent used in reconstitution or dilution. Read More
A Senate Appropriations subcommittee on Tuesday approved a bill that would provide $2.8 billion in discretionary funding for the FDA in fiscal 2018. Read More
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