FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/18/2017.
Human Drugs
Ritter Pharma Plans Phase 3 Study on Lactose Intolerance Drug
FDA provides guidance to Ritter Pharmaceuticals for it to begin a Phase 3 trial for RP-G28 for treating lactose intolerance.
Human Drugs
Vital Rx Recalls All Compounded Drugs After Inspection
Vital Rx (dba Atlantic Pharmacy and Compounding) recalls all lots of all compounded injectable prescription medications after a recent FDA inspection ...
Human Drugs
FDA Draft Guide on Drug Supply Chain Security
FDA issues a draft guidance on Identifying Trading Partners Under the Drug Supply Chain Security Act that explains requirements for the various types ...
Human Drugs
FDA Announces 3 Upcoming Generic Drug Workshops
FDA announces three upcoming generic drug development workshops in October.
Human Drugs
FDA Grant for Protalex Immune Thrombocytopenia Study
FDAs Office of Orphan Products Development awards Protalex a $403,000 grant to support future clinical development activity of PRTX-100 as a treatment...
Human Drugs
Comments Sought on Limited Risks DTC Major Statement
FDA announces the availability of a public docket for submitting comments about the development of recommendations regarding the content of risk infor...
Human Drugs
Bella Pharma Recalls Sterile Drug Products
Bella Pharmaceuticals recalls all lots of unexpired sterile drug products due to lack of sterility assurance.
Medical Devices
FDA Continues Aggressive Investigation on Magellan Tests
FDA says it continues to aggressively investigate Magellan Diagnostics LeadCare and LeadCare II blood lead testing systems due to concerns they may un...
