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TXT Info on DTC Promotion Sent to OMB [46 Words] [ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on experimental study of direct-to-consumer promotion directed at adolescents to the Office of Management and Budget.
TXT Breakthrough Designation for Pancreatic Cancer Therapy [118 Words] [ Price : $8.95]
FDA grants a breakthrough designation to Aduro BioTech for its pancreatic cancer combination treatment that consists of its CRS-207 and GVAX pancreas immunotherapies.
TXT Panels to Discuss Testosterone Replacement Therapy [100 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Bone, Reproductive and Urologic Drugs and the Drug Safety and Risk Management Advisory Committees will meet 9/18 to discuss a testosterone replacement therapy in males.
TXT OPDP Letter Cites Concordia Phone Promo Script [200 Words] [ Price : $8.95]
CDER’ Office of Prescription Drug Promotion sends Concordia Pharmaceuticals an untitled letter that cites a telephone script directed at physicians for Kapvay (clonidine hydrochloride) extended-release tablets.
TXT FDA Part of Probe Into FedEx Illegal Drug Courier Service [226 Words] [ Price : $8.95]
FDA criminal investigators contribute to U.S. government charges against FedEx for allegedly conspiring with two online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without required prescriptions.
TXT House Reps Want Info from FDA on Generic Labeling Proposal [396 Words] [ Price : $8.95]
House Oversight and Government Reform Committee chairman Darrell Issa (R-CA) and other representatives ask FDA for more information on its proposed rule to allow generic drug makers to make labeling changes when new safety information arises.
TXT CA Court Allows Celgene Whistleblower Case to Proceed [287 Words] [ Price : $8.95]
A California federal court rules that a whistleblower and former Celgene sales representative can proceed with her False Claims Act lawsuit against the company.
TXT FDA Moving Ahead with DTC Study of Adolescent Perceptions [323 Words] [ Price : $8.95]
FDA says it is moving forward with a proposed “Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents.”
TXT Healthcare Provider Concern on FDA Labeling Proposal: GPhA [273 Words] [ Price : $8.95]
The Generic Pharmaceutical Association submits a survey to FDA that reveals healthcare providers have serious concerns about the agency’s proposed rule on generic drug labeling.
TXT Janssen Biotech to Begin Study in Multiple Myeloma [109 Words] [ Price : $8.95]
Janssen Biotech plans a new Phase 3 study in the fourth quarter of this year of daratumumab in mulitple myeloma patients ineligible for stem cell transplantation.
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