Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior policy advisor for global compliance in the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).   Higgins outlined some of the consequences that can occur when these variables are not controlled, includin...

A proposed reorganization of the Food and Drug Administration Office of Regulatory Affairs (ORA) will “modify things significantly” for foods as well as medical products and is expected to be finalized this fall, said Janet Woodcock, the agency’s principal deputy commissioner at a 2 March webinar sponsored by the Alliance for a Stronger FDA.   Woodcock offered an update, yet few specifics, on the proposed restructuring of ORA, first floated on 31 January. Key among the...

The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...

The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.   The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be dee...

The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...

A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.   The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the pilots on 24 June. The group said that the pilots were prompted by its July workshop which “highlighted the need for more convergence on CMC [chemistry, manufac...

CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting ...

The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s COVID-19 pandemic restrictions. So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER), who provided an update on the center’s activities and priorities for 2022 at the Food and Drug ...

The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...

This article examines the US Food and Drug Administration’s (FDA) return to inspections that were put on hold during the ongoing COVID-19 pandemic. It outlines the agency’s oversight of drug and biological products during the pandemic and its plans moving forward. The authors summarize the agency’s guidance and policies, industry considerations, and recommendations to manufacturers preparing for their next FDA inspection.   Keywords FDA, inspections, quality, risk m...

Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.   At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the u...

The US Food and Drug Administration (FDA) unannounced foreign inspections program has resumed in India but is still paused in China due to local COVID-19 restrictions, Judith McMeekin, FDA associate commissioner for regulatory affairs, said on 6 April during a webinar sponsored by the Alliance for a Stronger FDA.   Members of Congress have expressed concern that FDA’s drug inspection program is inadequate to meet the meet the growth in foreign drug manufacturing facili...