Two Polsinelli attorneys say the Supreme Court’s refusal to hear an appeal in a labeling case helps manufacturers argue for preemption.
Philips Respironics recalls its Trilogy Evo ventilator and all software versions, except 1.05.06.00, due to the device’s potential for sudden loss of ventilation.
Two Polsinelli attorneys say the Supreme Court’s refusal to hear an appeal in a labeling case helps manufacturers argue for preemption.
Philips Respironics recalls its Trilogy Evo ventilator and all software versions, except 1.05.06.00, due to the device’s potential for sudden loss of ventilation.
Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advisory role in its drug development activities.
PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.
