A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

Recruiting generics firms to the AMR Industry Alliance is a key area of focus for the group as part of its efforts to cover a greater proportion of the global supply of antimicrobials, according to the Alliance’s latest report.

December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.