Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to COVID-19-related travel restrictions to continue on a routine basis.

Brigham and Women's soldiered on as water gushed and microorganisms blossomed, potentially compromising sterility of injectable drugs, warning letter says. The focus was on PET drugs, but there could be implications for decentralized manufacture of personalized medicines like cell and gene therapies in health care settings.

Draft guidance explains how agency intends to consider therapeutic context in benefit-risk framework to, in rare cases, set aside CMC issues for later resolution under "quality postmarketing agreements."