Draft gives non-penicillin ops guidance

The FDA expects manufacturers to treat sensitizing non-penicillin beta lactam antibiotics the same way they treat penicillin: using production facilities that are separate or isolated from those used for other products. Good manufacturing practice dictates "appropriate separation and control systems to prevent cross contamination," according to new draft guidance.

The guidance aims to help manufacturers determine whether separate facilities should be used based on the risk of cross-reactivity.

Like penicillin, the non-penicillin beta lactam drugs may be sensitizing agents. Cross-contamination can cause drug-induced hypersensitivity reactions in patients, including life-threatening anaphylaxis.

- see the draft guidance


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.