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Article FDA Thank You In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue

Agency IQ

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. They were not purchasing mifepristone.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

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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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

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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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

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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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

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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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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The FDA and Feasible Alternative Designs

Drug & Device Law

In at least the short term, a popular pain reliever would have to be removed from pharmacies. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices.

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