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BETHESDA, MD ­­­— Lilun Murphy, the director of the US Food and Drug Administration's Office of Generic Drugs (OGD), issued a warning to manufacturers regarding a recently identified leachable nitrosamine in certain drug products that are packaged in infusion bags.

The US Food and Drug Administration (FDA) hopes to obtain private sector help to improve nine areas of regulatory science, including the evaluation of generic drug effectiveness and expedited ways to assess drugs to treat the world's most dangerous diseases, the agency said this week in a new Broad Agency Announcement (BAA).

The US Food and Drug Administration (FDA) rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to 1 September, standing firm on the 1 March deadline.

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top agency official. She emphasized that companies need to treat risk management as an ever-evolving responsibility.

Critics of the US Food and Drug Administration's (FDA) accelerated approval pathway have focused on the need to generate confirmatory evidence faster and to withdraw products that fail to show benefit. But officials in FDA's Oncology Center of Excellence (OCE) suggest that focus is also needed on different trial designs and end points that could help build quality and efficiency into the front end of the process.

The US Food and Drug Administration (FDA) has announced that it will give drugmakers more time to conduct testing for nitrosamine drug substance-related impurities (NDSRIs) in approved pharmaceuticals if they cannot meet the 1 August 2025, deadline. Manufacturers will need to submit progress reports during this extended period.

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during inspections of manufacturers, according to a US Food and Drug Administration (FDA) official who spoke at the Orange County Regulatory Affairs Discussion Group annual conference last week.

The US Food and Drug Administration held a question-and-answer webinar on 9 April to help the generic drug industry avoid problems with their Type II active pharmaceutical ingredient (API) drug master files (DMFs). Such mishaps can potentially derail the agency's on-time review of generic drug applications.

The pharmaceutical industry needs to closely evaluate suppliers' testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products. Not questioning dubious results can wreak havoc and unnecessarily flag high levels of impurities where none may exist, warned an official from Perrigo at a 31 August webinar.