FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

FDA Law

AUGUST 21, 2023

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

OCTOBER 31, 2024

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

FDA Law

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs).

Manufacturing 52

Manufacturing Insurance Government Patients 52