FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups

The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting specifications. A research laboratory also received a warning for not complying with good laboratory practices, specifically regarding the detail of animal study reports.

A separate study reported that more than half of patient and consumer representatives attending FDA advisory committee meetings have connections to organizations with active ties to the pharmaceutical industry.

These developments raise concerns about regulatory compliance and potential conflicts of interest, underscoring the need for stricter oversight and greater transparency in FDA processes.