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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FDA issues a draft guidance on Identifying Trading Partners Under the Drug Supply Chain Security Act that explains requirements for the various types ...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...

Human Drugs

FDA Approves AstraZenecas Lynparza for Expanded Use

FDA approves an AstraZeneca NDA for Lynparza (olaparib) and its use as a maintenance treatment in certain adults with recurrent, epithelial ovarian, f...