FDA is understood to have decided to approve the emergency contraceptive as a new, third class of product, which would restrict access but not require a prescription.

Modification to ‘reasonable and necessary’ definition in MCIT final rule offers new avenue for drug manufacturers to get products covered in Part B. The Biden Administration will have to decide whether it will keep the Trump regulation unchanged.

The intensely negative advisory committee for Biogen’s proposed Alzheimer’s therapy was a shocker. Would it have happened if US FDA had been able to convene an in-person event instead of a ‘virtual’ one?