Happy Tuesday and welcome to another edition of D.C. Diagnosis. Your author is still embarrassingly proud of his #healthpolicyvalentine. He’s also struck by both the House and Senate’s upcoming hearings on why vaccinations are important. As always, send tips and other comments my way: nicholas.florko@statnews.com. 

My god, does anyone at FDA sleep?

If you’re an FDA regulatory nerd, Friday was like Christmas. The agency released a whole bunch of new guidance on all sorts of topics. Below I’ve summarized what exactly FDA put out, in case you’re not like me and don’t enjoy reading a few hundred pages of agency minutiae.

• Compounding: FDA affirmatively said six substances can be compounded by small-scale pharmacies (This might not seem like a lot, but this day has been in the making since the drug compounding law was signed back in 2013.)
• Generic drugs: FDA explained how generic drug makers can apply for a new pathway created by Congress that guarantees them expedited review by FDA, as well as additional exclusivity. It’s for companies making older drugs that don’t currently have generic competitors.
• Medical Devices: There’s new advice on how FDA provides feedback to medical device companies after the agency inspects their factory.
• Regenerative Medicine: FDA finalized two guidances on its expedited approval pathway for regenerative medicine, which includes things like stem cells.

If you’re thinking ‘So what?’ — remember, FDA was closed for 34 days less than a month ago. Safe to say they’re back at full steam?