The FDA issued final guidance on software that drugmakers distribute with prescription medicines, setting out when app content counts as labeling, when it belongs in prescribing information and what must be submitted.
The FDA has cleared Wave Neuroscience's MeRT System, which uses a patient's EEG to personalize magnetic stimulation, as an adjunct PTSD treatment. The sham-controlled trial behind it is not yet published.
The FDA announced a Rare Disease Framework Initiative and a white paper setting out six commitments to make reviews of rare disease drugs more consistent, with a public meeting set for October 28.
The FDA finalized a rule allowing salt substitutes in 139 foods with federal standards of identity, from cheese to canned vegetables. Reformulation is voluntary; the rule takes effect December 14.
The FDA has granted 510(k) clearance to Motivista, a prescription smartphone app for negative symptoms of schizophrenia, after a 457-patient phase 3 trial showed a small-to-moderate benefit over a control app.
The FDA approved a surgical pulmonary valve for children that is implanted at about 13 mm and can later be widened by balloon catheter to 22 mm, which the agency says may reduce repeat open-heart surgery.
