Topic

regulation

Policy

FDA finalizes rules for drug companion apps, treating their output as labeling

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.

October 23, 20264 min read

Policy

FDA launches rare disease framework, says only 5% of conditions have a treatment

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.

October 14, 20263 min read