Sponsors conducting clinical trials of devices intended to treat benign prostatic hyperplasia (BPH) should conduct biocompatibility testing on the final, sterilized form of components that come in contact with patients.

Sponsors of antibacterial drug candidates to treat acute bacterial skin and skin structure infections (ABSSIs) should use either a noninferiority or superiority trial design, while superiority trial designs are recommended for milder skin infection treatment candidates, according to an FDA draft guidance.

Pediatric epilepsy patients should be entered in exploratory add-on anti-epileptic drug (AED) studies as soon as the dose for children is established, a final guideline by the European Medicines Agency (EMA) says.