§ 111565 Drug Device Approval Revocation

• •If the government says 'no' to a new medicine or medical tool, they can change their mind later.
• •They will only change their mind if they find good reasons to do so.
• •This rule has been around since 1996.

A company makes a new painkiller, but the government says it’s not safe and rejects it.

Later, the company shows new tests proving the painkiller is safe. The government can then say 'okay' and allow it.