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Federal Register

Workshop on Modeling/Simulation for Oncology Products

Federal Register notice: FDA announced a 2/1 public workshop entitled Best Practices in Modeling and Simulation for Oncology Products.

Federal Register

Regulatory Review Period Determined for Corlanor

Federal Register notice: FDA determines that for patent extension purposes the regulatory review period for Les Laboratoires Serviers Corlanor (ivabra...

Medical Devices

Grnenthal Gains Expedited Pathway Designation for Sealant

FDA grants Grnenthal an expedited access pathway designation for Vivo, a surgical sealant proposed for being an adjunct to standard closure techniques...

Human Drugs

FDA Approves B. Brauns Ecoflac Plus Container

FDA approves B. Braun Medicals 0.9% sodium chloride injection, USP in the Ecoflac Plus 500 mL container.

Human Drugs

New England Compounding Pharmacist Gets 8 Years

A federal judge sentences the former head pharmacist at New England Compounding Center to eight years imprisonment and other sanctions for his role in...

Human Drugs

Intersection of Heart Health and Breast Cancer

The American Heart Association says that more research is needed in the relationship between breast cancer and cardiovascular disease in women.

Human Drugs

Trump Again Urges Right-to-Try Passage

Speaking at a 2/1 Republican retreat in West Virginia, president Donald Trump again urges Congress to pass right-to-try legislation to allow patients ...

Human Drugs

FDA Taking Steps to Ease Saline Shortage: Gottlieb

FDA commissioner Scott Gottlieb describes steps being taken to address saline shortages during the difficult flu season.

Human Drugs

FDA Accepts Alnylam NDA for Patisiran

FDA accepts for priority review an Alnylam Pharmaceuticals NDA for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for tr...

Human Drugs

Conference Report on History and Practices of FDA

A Yale University conference raises seven drug policy issues for stakeholder consideration.