Office of New Drugs director Peter Stein shed some light on how the newly established Division of Rare Diseases and Medical Genetics will operate following the completion of the OND reorganization, drawing mixed reactions from industry speakers.
The soon-to-be established Division of Rare Diseases and Medical Genetics (DRDMG) will feature both a consultative rare disease group and an inborn errors group that reviews product applications, Office of New Drugs (OND) director Peter Stein explained.
During a panel discussion last month at the FDA/CMS Summit sponsored by the Pink Sheet's parent company Informa, Stein explained the rare disease group within DRDMG (a new division created by the ongoing OND reorganization) will provide advisory
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Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
