Opioid, NME, And Generic Drugs Changes Plotted In US FDA's 2018 Policy Roadmap
‘Better informed patients,’ ‘drug competition,’ ‘biosimilar innovation’ – as well as nutrition and tobacco goals will be achieved through guidances, promotional plans and other items FDA will develop over the next year.
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Gene Therapies: Safety, CMC Draft Guidances Coming From US FDA In 2018
Lengthy safety registries, extensive premarket testing for replication competent retrovirus, and manufacturing submission advice likely; pending CBER documents informed by review and approval of Novartis' Kymriah, Kite's Yescarta, and Spark's Luxturna.
FDA Commissioner Outlines Priorities For Tightening Oversight Of Drug Compounding Facilities
To encourage drug compounding pharmacies to register as 503B drug outsourcing facilities, FDA plans to propose assigning these pharmacies a lower risk category, thus subjecting them to less stringent GMP controls if they make limited volumes of drugs as part of a “2018 Compounding Policy Priorities Plan” announced by FDA Commissioner Scott Gottlieb.
Disease-Specific Drug Development Guidances Coming From US FDA In 2018
Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.