FDA Law Blog: Biosimilars

APRIL 8, 2024

pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. For example, DEA and FDA jointly acknowledged in an August 1, 2023 letter that there have been ongoing shortages of various stimulant medications (e.g., Section I.C

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Drug & Device Law

JULY 24, 2023

3d , 2023 WL 4191651 (C.D. PATDC82 II , 2023 WL 4191651, at *3. the relationship between [plaintiff] and its pharmacy benefit manager. . . Apparently, massive loss of evidence was merely a “usual and customary service” of pharmacy benefit mangers nationwide. 2023 WL 4191651, at *8. 2023 WL 4191651, at *8.

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Drug & Device Law

FEBRUARY 20, 2023

In at least the short term, a popular pain reliever would have to be removed from pharmacies. 2023 WL 1192538 (Mag. 27, 2023), which we discussed here , addressed at length the plaintiff’s attempt to rely on “alternatives” that “existed,” but “were not yet cleared by the FDA for the purpose of treating” the plaintiff’s condition.

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