FDA Law Blog
SEPTEMBER 30, 2024
CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.
FDA Law Blog
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.
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FDA Law Blog
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.”
FDA Law Blog
FEBRUARY 4, 2025
The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.
Tiny Physician
OCTOBER 17, 2021
On the brighter side, daily case count drastically decreased and vaccination drive is happening at top speed. Almost 1 billion doses of vaccine have been administered so far and the situation is currently under control. Budget 2019: In fillip to traditional medicine, AYUSH ministry gets Rs 1,939.76 Arsenic Toxicity 8.
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