FDA Law Blog
JUNE 7, 2023
Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). N/A June 30 The manufacturer must accept the price or counteroffer—with a rationale. CMS may respond to the counteroffer.
FDA Law Blog
JUNE 15, 2022
Kirschenbaum — In 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule to significantly decrease the rate the government will reimburse 340B hospitals in 2018 for outpatient prescription drugs from average sales price (“ASP”) plus 6% to ASP minus 22.5%. By Faraz Siddiqui & Alan M. 52494 (Nov.
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Tiny Physician
OCTOBER 17, 2021
The Kerala government has taken off all the restrictions imposed due to the case surge as caseload has come down, and is also planning to restart schools from the second half of November. al had published a case series way back in 2003 on Arsenic toxicity after consuming homeopathic medicines in which Arsenic was added therapeutically (8).
FDA Law Blog
JULY 12, 2021
The Secretary of Health and Human Services is directed to submit to the White House, by August 23, a plan to “combat excessive pricing of prescription drugs and enhance domestic pharmaceutical supply chains, to reduce pries paid by the Federal Government for such drugs, and to address the recurrent problem of price gouging.”
FDA Law Blog
JANUARY 9, 2024
After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c).
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