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13

Gen

US Omnibus spending bill expands FDA’s unannounced foreign inspections pilot

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 year’s budget. 
 
Section 3615 of the omnibus spending bill allocates $10 million for the pilot. The legislation requires FDA to conduct a pilot program to increase the conduct of unannounced surveillance inspections of foreign drug establishments.
 
The pilot is intended to evaluate the differences in the number and type of violations identified during unannounced and announced inspections of foreign drug establishments and any other significant differences between each type of inspection.
 
The pilot will also weigh the costs and benefits associated with conducting announced and unannounced inspections of foreign facilities, identify the barriers to conducting unannounced inspections of foreign sites and identify any challenges to achieving party between domestic and foreign human drug inspections...

After completion of the pilot, FDA is required to issue a report on its website identifying its findings and recommendations with respect to evaluating and addressing any barriers to conducting unannounced foreign inspections. The report should also offer recommendations for achieving parity between domestic and foreign drug inspections and include the number of unannounced inspections during the pilot. This report should be submitted to Congress within 180 days of the pilot’s termination.
 
Members of Congress have been critical of FDA’s practice of preannouncing foreign drug inspections well in advance of the actual inspection, arguing that this practice raises serious questions about the effectiveness of the inspections when firms know when investigators will be visiting. Previously, the FY 2022 appropriations bill directed FDA to pilot an unannounced inspections program in India and expand it to China for short unannounced and short-term inspections....[RAPS]

24

Mar

AIFA - Criteri per l’attribuzione di distinti numeri di AIC in fase di domanda di nuova AIC/estensione o a seguito di variazione

Si informano i Titolari AIC che, al fine di rendere trasparenti i criteri adottati dall’Agenzia...

23

Mar

IMS Micronizzazioni: “Making Pharmaceuticals per parlare delle ultime novità in campo di micronizzazione”

Il settore farmaceutico si riunisce a Milano per fare il punto sulle ultime novità e sulle prospettive...

23

Mar

EDQM - What is the CEP 2.0 and what will change?

The CEP 2.0 (new name of the CEP of the future) is a “new-look” CEP that will better meet...

17

Mar

EMA - EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME

Audit Checklist (Revision 3 including API and common with Canada and PIC/S).. [EMA]

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