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TXT FDA Denies 25 Petitions on ANCHOR Trial [443 Words] [ Price : $8.95]
FDA denies 25 petitions asking that it overturn its decision to rescind the SPA agreement for the ANCHOR trial of Amarin’s Vascepa.
TXT Latest FDA Warning Letters [1240 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites 1ViZN, L.L.C., Applied Medical Resources, Beta Labs, Better Body Sports, Aaron Singerman Blackstone Labs, Brand New Energy, Core Nutritionals, Genomyx, Hi-Tech Pharmaceuticals, Human Evolution Supplements, Iron Forged Nutrition dba TGB Supplements, Martin Avenue Pharmacy, Nutrex Research, Powder City, Prime Nutrition, RPM Nutrition, Train Naked Labs LLC, Tribravus Enterprises, and Vital Pharmaceuticals.
TXT Woodcock to Senate: ‘Unfunded’ Mandates Could Hurt Reviews [1086 Words] [ Price : $8.95]
During a Senate hearing on pending legislation to help medical product innovation, CDER director Janet Woodcock warns lawmakers that product review activities could be slowed if the agency is given more duties than it can handle.
TXT Senate, House Democrats Urge FDA to Finalize Labeling Rule [264 Words] [ Price : $8.95]
Senate Judiciary Committee ranking member Patrick Leahy (D-Vt.) and 46 other House and Senate Democratic urge FDA to ignore a brand-innovator alternative and finalize its 2013-proposed rule that would give generic drug makers the authority to update their warning labels as new information becomes available.
TXT FDA Alert on Flurbiprofen Danger to Pets [194 Words] [ Price : $8.95]
FDA recommends that consumers who use topical medications containing flurbiprofen take precaution to prevent their pets from being exposed to them.
TXT Senate Bipartisan Bill on Device Breakthrough Therapies [166 Words] [ Price : $8.95]
Senators Richard Burr (R-NC), Michael Bennet (D-CO), and Orrin Hatch (R-UT) introduce the Advancing Breakthrough Devices for Patients Act that is intended to help speed approval of breakthrough devices.
TXT FDA, Medtronic Enter Consent Decree on Infusion Pump Problems [372 Words] [ Price : $8.95]
FDA files a consent decree against Medtronic and two of the company’s officers — S. Omar Ishrak and Thomas M. Tefft — for repeatedly failing to correct violations related to its Synchromed II Implantable Infusion Pump systems.
TXT FDA Finding More Bioresearch Monitoring Violations [358 Words] [ Price : $8.95]
FDA sees an increase in violations during clinical investigator inspections.
TXT FDA Questions Approvability of Amgen’s Melanoma Therapy [155 Words] [ Price : $8.95]
Amgen faces an uphill battle in gaining approval for its cancer-targeting virus talimogene laherparepvec (T-Vec) as FDA reviewers question data contained in its BLA.
TXT FDA Clears FH Ortho Shoulder Device [104 Words] [ Price : $8.95]
FDA clears an FH Ortho 510(k) for the Arrow Reverse Shoulder “long keel” and “short keel” glenoid base plate for use in shoulder surgeries.
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