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FDA concerned about surge in biosimilar workload

FDLI SmartBrief | Feb 08, 2016

The FDA's Biosimilar Product Development Program has enrolled 59 proposed biosimilars for 18 reference products as of late January, which is straining the capacity of the agency's staff, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in congressional testimony. Woodcock says she anticipates those numbers to climb substantially. BioCentury (02/05)


FDA to change opioid drug evaluation, approval policies

FDLI SmartBrief | Feb 05, 2016

Obama seeks funding to create Zika vaccine, fight virus

FDLI SmartBrief | Feb 09, 2016

Rules that aim to cut contamination in turkey, chicken products released by USDA

FDLI SmartBrief | Feb 05, 2016

Supernus wins patent infringement case against Allergan

FDLI SmartBrief | Feb 08, 2016

Studies link smoking bans to lower CVD hospital admissions

FDLI SmartBrief | Feb 04, 2016

Celltrion's Remicade biosimilar gains FDA staff support

FDLI SmartBrief | Feb 08, 2016

Congress urged to act quickly on national biotech food labeling policy

FDLI SmartBrief | Feb 05, 2016

Dry-eye-disease treatment from Shire accepted for FDA review

FDLI SmartBrief | Feb 05, 2016

FDA OKs migraine drug from Dr. Reddy's Laboratories

FDLI SmartBrief | Feb 04, 2016


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