· 3 min read
On December 29, 2022, President Biden signed into law the fiscal year 2023 appropriations bill. This provides financing for several changes to the U.S. FDA’s drug manufacturing inspection program.
The FDA must now adjust each facility’s inspection priority ranking based on the compliance history of other establishments in its country or region.
Historically, the FDA has not announced domestic surveillance inspections but has announced foreign ones for logistical and other reasons.
The pilot will evaluate:
The spending bill revises the FD&C Act Section 704(a)(4) remote records review provision such that the FDA may inspect records and other information remotely rather than conduct on-site preapproval inspections and surveillance inspections, or to resolve deficiencies identified during inspections.
The spending bill revises Section 809 of the FD&C Act (21 USC 384e) to authorize reliance on foreign authorities not just for risk-based but also for preapproval inspections.
The bill requires information sharing on inspection and review activities related to mutual-recognition agreements with foreign authorities, with information broken down by regions of interest, including China, India, the EU and the UK.
The bill provides for enhanced coordination and transparency among field investigators and staff of CDER’s Office of Compliance and drug shortage program.
Public health and safety standards around the world are continually evolving. Make sure that you and your team are keeping up to date with the latest changes in legislation and regulations by participating in training with NSF experts.
Less than two weeks after the publication of revision 13 of the EMA Q&A on nitrosamines, revision 14 was published on December 22, 2022. This revision updates three Q&As — 20, 21 and 22 — which deal with what happens if a nitrosamine is found that exceeds the acceptable intake (AI) limits:
The pharmaceutical regulatory update service provides you with 12 months of updates of changes to legislation and guidance that have the potential to impact the manufacture and distribution of medicinal/drug products. A full update for the past year and a summary of what is new each quarter will be provided in February, May, September and late November. This service is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development (CPD).
Complete your details below to receive the newsletter.
Join NSF at RAPS Convergence 2023
August 2023 Pharma News Update
July 2023 Pharma News Update