The White House's most recent Unified Agenda outlines several major drug and
device rules and proposed rules FDA intends to issue in the coming
year. The Unified Agenda is generally a good indicator of the
administration's priorities for the coming year; however, these
priorities can shift, and thus the dates are not firm.
In the medical devices realm, the Unified Agenda notes proposed
rules for making packaging and labeling inserts for home-use
devices available electronically, the format and content of
substantial equivalence reports, and several regarding radiologic,
mammography, and sun lamp devices. Final rules for medical devices
listed in the Unified Agenda concern the use of certain symbols in
labeling, laser device performance standards, and postmarket safety
reporting for combination products.
In the area of drugs and biologics, the Unified Agenda lists
proposed rules forthcoming on the topics of abbreviated new drug
applications and related patent issues, electronic prescribing
information, investigational new drug annual reporting, current
good manufacturing practices for drug product outsourcing
facilities, regulations on drug compounding, national licensing
standards for prescription drug wholesale distributors and
third-party logistics providers, and revoking the general safety
test regulations that duplicate biologic license application
requirements. Final rules listed for drugs and biologics include
establishment registration and listing requirements, labeling
requirements for pregnancy and lactation, revising reporting
requirements surrounding drug shortages, supplemental applications
proposing labeling changes, drugs that have been removed for
reasons of safety or effectiveness, and administrative destruction
of drugs that are refused admission to the United States.
The Unified Agenda also contained a half dozen anticipated
proposed or final rules regarding various
over-the-counter drug products and a final rule regarding
blood products for transfusion or further processing.
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