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Drugmakers seeking approval of osteoporosis candidates should bolster their submissions with nonclinical pharmacology studies to determine adverse effects, the FDA advises. Read More
The House Energy and Commerce Committee passed by a voice vote Wednesday a measure that would ensure tropical disease priority review vouchers are not issued to products with regulatory approval in other countries. Read More
The FDA is spelling out the criteria for expanded access to investigational drugs in three final guidances to make the process as clear as possible. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More