 New FDA Proprietary Name Requirements May Affect Review ClockThe FDA may refuse to start the review clock for NDA, BLA and ANDA proprietary name submissions if they are not complete as described in a new final guidance. Read More
Watson Revises Generics Focus to Achieve $600 MillionWatson Pharmaceuticals has realigned its sales force following its acquisition of Arrow Group to increase its focus on urology, obstetrics and gynecology treatment areas and certain primary care markets. Read More
Cephalon Physician Payments Go Public Following CIACephalon is disclosing payments to physicians and related entities as required by a corporate integrity agreement (CIA) it entered in a settlement with the HHS Office of Inspector General. Read More
Lack of Foreign MDRs Results in Warning to ELA MedicalFrench devicemaker ELA Medical has been warned for not reporting adverse events that occurred outside the U.S. involving the same devices it distributes in the U.S. Read More
Sebelius Highlights Inspections, Biosimilars in Congressional TestimonyIncreasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the FDA’s fiscal 2011 budget request, HHS Secretary Kathleen Sebelius says. Read More
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Lack of Foreign MDRs Results in Warning to ELA MedicalFrench devicemaker ELA Medical has been warned for not reporting adverse events that occurred outside the U.S. involving the same devices it distributes in the U.S. Read More
Inspector General: More Oversight Needed of Research Conflict-of-Interest PoliciesIf research institutions do not voluntarily strengthen their conflict-of-interest policies and procedures, pressure for external regulations is likely to increase, HHS Inspector General Daniel Levinson said as he called on the FDA and NIH to step up their oversight. Read More
DOE Awards Grants to Create Domestic Supply of IsotopeTwo grants from the Department of Energy (DOE) may alleviate long-term shortages of a medical isotope commonly used in diagnostics, but suppliers of technetium-99m (Tc-99m) are still looking for short-term solutions. Read More
Diagnostic Study Results Misrepresented by WebsiteBracco Diagnostics made false and unsubstantiated claims about its diagnostic agent Isovue and omitted or minimized risks on a website that based
the claims on a clinical study, an FDA untitled letter says. Read More
Attorneys: Court Ruling Means Trouble for DevicemakersA verdict against
I-Flow over off-label use of its pain pump could set a precedent leading to more verdicts against other pain pump makers, Robert Jenner, an attorney at
the Janet, Jenner & Suggs law firm, says. Read More
Watson Revises Generics Focus to Achieve $600 MillionWatson Pharmaceuticals has realigned its sales force following its acquisition of Arrow Group to increase its focus on urology, obstetrics and gynecology treatment areas and certain primary care markets. Read More
Cephalon Physician Payments Go Public Following CIACephalon is disclosing payments to physicians and related entities as required by a corporate integrity agreement (CIA) it entered in a settlement with the HHS Office of Inspector General. Read More
Sebelius Highlights Inspections, Biosimilars in Congressional TestimonyIncreasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the FDA’s fiscal 2011 budget request, HHS Secretary Kathleen Sebelius says. Read More
GSK Works With eBay to Stop Online Counterfeit Alli SalesGlaxoSmithKline (GSK) is working with eBay to remove online auctions of counterfeit Alli and inform consumers about potentially counterfeit product sold on similar websites. Read More
FDA, PATH Agreement Could Lead to Clinical Trials for VaccinesThe FDA has entered an agreement with the nonprofit PATH that could lead to several clinical trials of pneumococcal vaccines for children in developing countries. Read More
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