The Pharma Data

MAY 14, 2021

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

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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PLOS: DNA Science

APRIL 4, 2024

” The Patent Trail Rather than relying on social media, company websites, and testimonials, I consulted the Patent and Trademark database to reconstruct the story of invention. If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. ” Lady parts.

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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.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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.

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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 11, 2023

Cities have cited low detections of PFAS as well as the expectation that payments would be too low to fund remediation efforts to bring the city or municipality into compliance with future state or federal water regulations for PFAS. On November 27, 2023, the La Crosse Common Council (WI) voted unanimously to opt out of the settlement.

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FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. AG Garland opined during his confirmation that he did not think it the best use of DOJ’s limited resources to prosecute those who are complying with the laws in those states that have legalized marijuana and are effectively regulating it. 1, 2023 ( 02:38:46 ).

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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

scientific trials and regulations, modern medicine by. Just read and watch the testimonials for. 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. small or if a medication doesn’t have any side. What they say.

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The Pharma Data

MAY 14, 2021

Their waists got smaller… They also saw an improvement in fat-regulating hormones. And serves as your body’s “master regulating switch.” As a result, they dropped their body mass index (BMI) levels from 31.5 They also lost belly fat…. Without completely overhauling your diet. . When I came across this one….

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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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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. It was like the floodgates burst wide open…. And the fat just came pouring off. When your thyroid isn’t producing enough of its two main hormones – T3 and T4…. So what’s the fix here?

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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

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 5, 2022

The linchpin of J&J’s Due Process arguments is the concept of “fair notice.” “A fundamental principle in our legal system is that laws which regulate persons or entities must give fair notice of conduct that is forbidden or required.” FCC v. at 27 (testimony that “large” amount of material had to be “recycl[ed]”).

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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. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Sullivan , OAJC, 2023 WL 8859656, at *11.

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Drug & Device Law

JANUARY 24, 2022

Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Valsartan Testimony ¶3. PPI ¶11 (participants must “comply with any government law, regulation or guidance regarding public health and safety during the COVID-19 pandemic”). All depositions. . . H/C ¶1(A); accord Zantac ¶22. Generic Pharmaceuticals Pricing ¶14.

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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 28, 2023

In a paraphrase of the testimony of a difficult opposing epidemiology expert who passed away recently, “you have to say what you will do and then do what you say.” including all neurodevelopmental issues to get an increased risk in a study that was only designed to look at ASD).)

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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.) Could such “notice” have a chilling effect? Yes, of course.

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Drug & Device Law

JUNE 1, 2022

Our favorite part of the plaintiff’s case was the reliance on unsworn affidavits and prior testimony by a Dr. Kory, who stated that he is “generally considered the foremost expert” on the proposed Covid treatment. One doctor wrote an ivermectin prescription based solely on statements from the patient’s wife.

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Drug & Device Law

FEBRUARY 20, 2023

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. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives.

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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). Moline has given testimony in many other cosmetic talc cases” while keeping the (at least potentially) false premise of her article secret supported disclosure of the contrary evidence. 11-17 (Jan. It got worse. quoting 45 C.F.R.

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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

MAY 30, 2023

Which means they are also familiar with Touhy regulations and the frequency with which those regulations are used to deny requests for medical records and depositions in civil litigation. While the VA provided some discovery, it denied the large majority of the requests under their Touhy regulations.

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Drug & Device Law

JULY 27, 2022

In Wood, the plaintiffs moved to exclude testimony by the defense regulatory expert, while the defense moved to exclude or limit materials science and medical causation experts. The plaintiff argued that such testimony was irrelevant and confusing, because the 510(k) clearance had nothing to do with safety.

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Drug & Device Law

MARCH 9, 2022

The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. When we consider the damage a regulatory expert can do, misinterpreting both company documents and FDA regulations to make the company look like Murder, Inc., How does such testimony meet the relevance requirement of Fed. Evidence 402?

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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

FEBRUARY 21, 2022

The defendant sought Pence’s exclusion because “she is not qualified due to her lack of education, experience, or specified knowledge about the regulation of medical devices, specifically the defendants’ mesh.” Plaintiff’s] argument that [her] testimony has been admitted in other cases is not persuasive. Coloplast Corp.

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Drug & Device Law

SEPTEMBER 12, 2023

Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic. There are also FDA regulations that state that for a powder, the serving size must contain a “reference amount” of 2 grams. While consumers don’t have to adhere to FDA regulations in measuring their servings, the manufacturer does.

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Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” That testimony was contrary, not only to the common-law cases discussed in our prior posts , but also flatly contradicted §801.109(c). 801.109(c).

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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

MARCH 28, 2022

A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.

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