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 20, 2023

In the United States, the Environmental Protection Agency (EPA) has developed a PFAS Roadmap and proposed numerous regulations for managing the effects PFAS has on the environment and human health. TSCA also focuses on regulating chemical substances which may present an unreasonable risk of injury to health or the environment.

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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. Government shutdown: At present, the FDA has appropriated funding through January 19.

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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. N Engl J Med.

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The Pharma Data

MAY 13, 2021

I got hot flashes at the most embarrassing times (like when giving a presentation at work)… I would get out of breath just from running up a flight of stairs…. Then these hormones can’t regulate your metabolism like they should…. Even when they were presented with stressful situations…. My joints were sore and achy….

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The Pharma Data

MAY 13, 2021

scientific trials and regulations, modern medicine by. Just read and watch the testimonials for. the material presented on this Site, E-Book and Program. you were to ask most doctors about ADRs, they would. give you one of the answers I used to give: The. risks of any one person having a problem is pretty. What they say.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Through relationship-building and increased engagement, regulators aim to improve their understanding of the ‘lived experience’ of patients with rare diseases and hear their top concerns. For example, Voice of the Patient and Patient-Focused Drug Development meetings are focused on one disease or a group of similar diseases.

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Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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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

22 (both articles for the proposition that there are “‘many intense side effects’ and ‘significant complications requiring medical attention’” resulting” from FDA’s regulation of mifepristone), at *22 n.37 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. We were hardly alone.

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Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. Our entire jury system relies upon the adversarial presentation of evidence and argumentation. at 527 (citation and quotation marks omitted).

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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

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. Rather than examine the actual bases of those opinions, as Rule 702(b) required, Crockett waved the testimony through with the single observation that the expert claimed to have “conducted a “detailed review of the literature.”

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Drug & Device Law

DECEMBER 20, 2023

Despite the chorus of criticism of recent Congressional testimony by a trio of tone-deaf college presidents, there really is a valid, if sometimes difficult, distinction between speech and conduct.) But it is easy for us; we’re not facing a criminal conviction or presentence report.) Could such “notice” have a chilling effect?

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Drug & Device Law

AUGUST 24, 2023

The court exercised its “gatekeeping” function under Rule 702 to assess whether the methodology underlying Plaintiff’s proffered expert testimony was “scientifically valid” and whether it could “be [properly] applied to the facts in issue.” Nor could Plaintiff fill that void by relying on expert testimony from other cases.

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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

FEBRUARY 20, 2023

Thus, “[e]ven assuming arguendo that [plaintiff’s alternatives] were alternative designs and were safer, there is no genuine issue of material fact presented regarding their availability in 2010.” 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Baksic relied on Pizzitola v.

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Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). The “reason” was “to allow for public access to data that undermines claims that plaintiffs’ experts and counsel continue to present to courts and factfinders.” 11-17 (Jan. It got worse. citation and quotation marks omitted).

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Drug & Device Law

MARCH 4, 2022

702 – that they were not qualified, their testimony was not based on sufficient facts or data, their methodologies were not reliable, and they did not reliably apply their methodologies to the facts of the case. their testimony does not present a genuine issue of medical fact.” Motion to Exclude Experts. emphasis in original).

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Drug & Device Law

JANUARY 24, 2022

To ensure that [witnesses] are not coached, ground rules should specify who may be present with the [witness] during the examination. The Manual also discusses general issues concerning the presentation of video depositions of any sort at trial. Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Valsartan Testimony ¶3.

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