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 anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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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.

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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

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

JUNE 17, 2024

They were not subject to any direct regulation by the FDA related to mifepristone. And in many cases, they had what the FDA had characterized as a “diametrically opposed” or “antagonistic” relationship with patients who have taken mifepristone at the direction of another medical provider. They were not purchasing mifepristone.

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Drug & Device Law

FEBRUARY 16, 2024

Plaintiffs included in their motion for reconsideration a lengthy affidavit contending that the court’s decision dismissing their failure to warn claim was based on the wrong physician’s testimony. If accepted, the testimony may have altered the court’s analysis in the second motion for summary judgment. Allied Mut.

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Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. We were hardly alone. See AHM I , 2023 WL 2825871, at *4 n.9

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