July 11, 2022 | Daily Business Review
Over-the-Counter Birth Control? Drugmaker Seeks FDA ApprovalHormone-based pills have long been the most common form of birth control in the U.S., used by millions of women since the 1960s.
By Matthew Perrone
6 minute read
February 09, 2022 | Daily Business Review
FDA's Agenda in Limbo as Biden's Nominee Stalls in SenateDr. Robert Califf, an FDA commissioner under President Barack Obama, was viewed as a safe choice who could easily clear the Senate, given his 2016 confirmation by an overwhelming vote, 89-4.
By Matthew Perrone
6 minute read
January 26, 2022 | Daily Business Review
DeSantis Blasts FDA For Halting Drugs Ineffective on OmicronThe FDA says omicron is responsible for more than 99% of U.S. infections, making it "highly unlikely" that the antibodies would be effective for people seeking treatment.
By Anthony Izaguirre and Matthew Perrone
4 minute read
November 09, 2010 | Daily Report Online
DOJ charges former Glaxo lawyer with obstructionWASHINGTON AP - Federal prosecutors said Tuesday they have charged a former GlaxoSmithKline lawyer with obstructing justice and making false statements in an effort to conceal illegal promotion of a company drug.The Department of Justice alleges that in 2002, Lauren Stevens of Durham, N.C., signed several letters to the Food and Drug Administration denying that her company had promoted its drug for unapproved uses.
By MATTHEW PERRONE
2 minute read
June 19, 2012 | Daily Report Online
Congress poised to pass safety-focused FDA billA bill designed to beef up the safety of the nation's prescription drug supply is poised to pass Congress, but without a tracking system that public health advocates say is critical to weeding out counterfeit pharmaceuticals.
By Matthew Perrone
4 minute read
March 06, 2009 | Daily Report Online
Dems move to overturn shield for device makersWASHINGTON AP - A day after the Supreme Court decided that federal rules do not protect drugmakers from state lawsuits, Democrats in Congress moved to overturn a decision that has shielded medical device companies from similar legal action.On Wednesday the court turned away Wyeth's claim that it could not be sued in state courts for its drug Phenegran, because it had already been approved by the federal Food and Drug Administration.
By MATTHEW PERRONE
3 minute read
April 26, 2013 | Daily Report Online
Senate bill targets large compounding pharmaciesLarge specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards under a new Senate proposal introduced Friday.
By Matthew Perrone
3 minute read
September 01, 2010 | Daily Report Online
Botox maker to pay $600M to resolve investigationWASHINGTON AP - Allergan Inc., the maker of wrinkle-smoothing Botox, says it will pay $600 million to settle a five-year-long federal investigation into its marketing of the top-selling, botulin-based drug.The company said Wednesday in a statement it will plead guilty to one misdemeanor charge of "misbranding," in which the company's marketing led physicians to use Botox for unapproved uses.
By MATTHEW PERRONE
3 minute read
March 22, 2013 | Daily Report Online
FDA: Georgia pharmacy recalling all sterile drugsThe Food and Drug Administration notified doctors Thursday that a Georgia compounding pharmacy responsible for a drug linked to eye infections has recalled all of its injectable medicines following a federal inspection.
By Matthew Perrone
3 minute read
March 10, 2009 | Daily Report Online
Judge in Medtronic case will not remove himselfWASHINGTON AP - A judge who dismissed thousands of lawsuits against Medtronic said Monday he will not remove himself from the case, despite criticism for not revealing that his son works for a law firm tied to the company.Lawyers for patients implanted with Medtronic's defective Sprint Fidelis defibrillator wires have called on Judge Richard Kyle to recuse himself from the case.
By MATTHEW PERRONE
2 minute read
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