CAPA, Validation Failings Prompt 483 at Canada’s RS Medical July 27, 2016 Storage conditions for rechargeable batteries triggered complaint. Read More
Safety Concerns Prompt EMA to Reassess Guidances July 27, 2016 Agency weighs updates on initial human testing protocols. Read More
India Places Coronary Stents on Drug List July 26, 2016 Change likely means price controls for stents. Read More
Industry Says PDUFA Proposal Balances Innovation and Safety July 26, 2016 Benchmark goals would cover next five-year cycle of PDUFA. Read More
Medtronic’s DBS Pocket Adaptors Receive Hazard Alerts July 25, 2016 Pocket adapters suffer from low current conductions. Read More
FDA Wants Big Changes From GSK Subsidiary on Penicillin Contamination July 25, 2016 Drug has been found in multiple parts of plant 187 times over three-year period. Read More
FDA Grants Emergency Use Authorization to Viracor-IBT for Zika Virus Test July 22, 2016 Molecular diagnostic tool detects RNA in fluids for the Zika virus. Read More
PDUFA Proposal Satisfies Companies by Accelerating Drug Approvals July 22, 2016 Drugmakers will be able to use patient-reported data to speed clinical development. Read More
BMS’ Orencia Autoinjector Hits the Market July 21, 2016 The device is for adults with moderate to severe rheumatoid arthritis. Read More
WHO Grants Pfizer Prequalification, Expands Prevenar 13 Access July 21, 2016 The prequalified version of Prevenar 13 is scheduled for release in early 2017. Read More
FDA Releases Guidance To Back EMC Claims July 20, 2016 The FDA provides a checklist of what manufacturers should include in their submissions. Read More
Pfizer Nabs Extended Indication for Prevnar 13 July 20, 2016 Prevnar 13 is now indicated for adults between the ages of 18 and 49. Read More