Mayo Clinic’s Chelsee Jensen, PharmD, discusses FDA policy changes, biosimilar development hurdles, denosumab lessons, and ...
A treatment for Barth syndrome, a rare and often fatal genetic disorder, faces unexpected FDA-related hurdles, NBC News reported Aug. 18. Approximately 150 people in the U.S. have Barth syndrome, a ...
The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019, is replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation ...
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