Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

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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. The chemo trial preceded Lume by more than a decade, so you’d think the product name would have been better researched. ” Lady parts.

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Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market. In a testimony in front of the U.S.

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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. De Araujo IE.

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Disease Production Testimonials Science 52

The Pharma Data

MAY 13, 2021

However, you’ll see the science. The science guys did the hard part. I even ended up as the Wellness Director for the International Sports Science Association. If you’re interested in more of the science of Lipase-P, I’ll cover much more later. Spend a few years in trial and error testing. That sounds bizarre.

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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. As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions.

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Drug & Device Law

DECEMBER 28, 2023

While Frye was seen as a high bar at the start, by the 1980s, a cadre of practitioners of the ancient art of junk science were routinely permitted to offer medical causation opinions at trial despite general causation being anything but generally accepted. The only thing missing was accusing the defendants of buying the science.

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Testimonials FDA Science Drugs 52

Drug & Device Law

DECEMBER 21, 2023

The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. There’s no science to back any of the allegations up – as demonstrated by the masterful (and even longer) take down of nearly identical substantive allegations in the Zantac ( 2022+4 ) MDL.

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FDA Approval FDA Drugs Production 52

Drug & Device Law

JUNE 13, 2023

702 was (at the time – more on this below) identical to the Federal Rule, the Court stated “we believe that Daubert is directed at situations where the scientific or technical basis for the expert testimony cannot be judicially noticed and a hearing must be held to determine its reliability. 2013) (citation and quotation marks omitted). “We.

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Testimonials Science Trials International 59

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 8, 2023

She prevailed at trial against one of the manufacturers and lost to the other. Reading between the lines, it looks to us that the court permitted the plaintiff side experts (one for materials science, the other for medical causation) to testify beyond their proper scope. The losing manufacturer appealed and lost again.

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Testimonials Trials Production FDA 59

Drug & Device Law

DECEMBER 28, 2022

Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.)

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Science FDA Testimonials Hospitals 59

Drug & Device Law

DECEMBER 27, 2022

Use of “results-based,” “conclusion-oriented,” and “situational science” methods. That is the antithesis of reliable science.”), 146. Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. at 83 (citation and quotation marks omitted). at *131-32.

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Laboratories FDA Production International 59

Drug & Device Law

NOVEMBER 28, 2022

Three years ago we published a lengthy post, “ Stupid Expert Tricks ,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies.

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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

JULY 25, 2022

[B]ecause the opinions in [the expert’s] report pertain only to transvaginal implantation, [the] testimony would be unhelpful to a jury. Accordingly the court grants [the] motion to exclude [the expert’s] testimony.” So far, so good. citation omitted). But the court also said this – the first of many similar comments: “. [D]isputes

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Drug & Device Law

FEBRUARY 28, 2022

at 287 (citing transcript of expert’s testimony). [A]t A]t first blush, [the expert’s] testimony. No other witness offered testimony on these unidentified standards. An excellent example is the Sherman case, which involved junk science causation testimony in what we call a “toxic soup” chemical exposure case.

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Drug & Device Law

FEBRUARY 25, 2022

The defendant first sought PLAC’s help on en banc rehearing, after suffering a loss on admission of expert testimony that we considered to be the worst decision of 2021. Notice how admissibility of expert testimony under Fed. In re Bair Hugger Forced Air Warming Devices Products Liability Litigation , No. 19-2899 (8th Cir. Finnerty v.

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Drug & Device Law

FEBRUARY 21, 2022

702 expert gatekeeping decisions bearing that caption, as Martinez approaches trial (scheduled for March 21, although the plaintiff has sought a continuance). Thus, Pence’s proposed testimony didn’t “fit” this case: There is no logical connection between her expertise, the issues in the case, and her opinions. pelvic mesh case.

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