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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The Pharma Data

MAY 13, 2021

Testimonials are not necessarily representative of all of those who will use our products. Some of our testimonials are provided by customers who have received promotional offers in exchange for their participation. The testimonials displayed are given verbatim except for correction of grammatical or typing errors. J Intern Med.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. For example, a 2016 study in the Journal of Environmental Health found that supplementing with these minerals led to higher levels of T3 and T4 in the bloodstream…iv. Along with the amount of estrogen-regulating DIM that he added as well.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Drug & Device Law

DECEMBER 29, 2023

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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Drug & Device Law

FEBRUARY 11, 2024

On appeal, the Fifth Circuit overturned the District Court’s nullification of the FDA’s approvals of both branded and generic versions of mifepristone but affirmed that court’s voiding of both the 2016 risk evaluation and mitigation strategy (“REMS”) and 2021 non-enforcement decision that allowed telemedicine prescription of mifepristone.

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FDA Production FDA Approval Regulations 59

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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