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.

FDA 40

FDA Science Regulations Production 40

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.

Disease 52

Disease Production Testimonials Science 52

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.

Treatment 52

Treatment Doctors Production Disease 52

Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

Clinical Research 72

Clinical Research Disease Research Clinical Trials 72

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.

FDA 40

FDA Science Biosimilars Regulations 40

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. and [defendants’] response thereto, the trial court did not abuse its discretion by disallowing the evidence. Ethicon, Inc. , 3d 1245 (N.J.

Compliance 52

Compliance Government Production FDA Compliance 52

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.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

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. Yet Dr. Baccarelli never conducted separate and distinct analyses for ASD and ADHD.

Testimonials 52

Testimonials FDA Science Drugs 52

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.”

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

DECEMBER 20, 2023

So we got this prosecution, a trial, a verdict, and some interesting motions. After a thirty day jury trial, the two executives were found guilty of multiple misdemeanor violations of the Food, Drug, and Cosmetic Act, but were acquitted of the felony accounts. The trial court refused to give such an instruction.

Trials 52

Trials FDA Production Testimonials 52

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.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

FEBRUARY 20, 2023

That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. See Davis v.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

DECEMBER 5, 2022

Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap. The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.” at 27 (testimony that “large” amount of material had to be “recycl[ed]”).

Testimonials 64

Testimonials Doctors Production Trials 64

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. 3d 179, 181-87 (D. 11-17 (Jan. It got worse. quoting 45 C.F.R.

Testimonials 59

Testimonials Regulations Research International 59

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.

Testimonials 59

Testimonials FDA Production Trials 59

Drug & Device Law

MARCH 30, 2022

Several of the rulings in Enborg are common to numerous mesh decisions out there, but there is a favorable decision about Rule 30(b)(6) deposition testimony not being a judicial admission that we have not seen addressed before in any detail. Consequently, the court denied the plaintiffs’ motion to exclude the expert testimony.

Testimonials 59

Testimonials FDA Trials Regulations 59

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.

Testimonials 59

Testimonials FDA Regulations Production 59

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?

Testimonials 64

Testimonials FDA Doctors Regulations 64

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).

Testimonials 59

Testimonials FDA Approval FDA Regulations 59

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). Id. “None” of her “publications has any connection to “conducting clinical trials for medical devices or post marketing surveillance for medical products.” pelvic mesh case.

Testimonials 59

Testimonials Clinical Trials Production Trials 59

Drug & Device Law

JANUARY 24, 2022

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. Numerous MDLs have entered orders authorizing remote depositions during the COVID-19 pandemic. 2972, Stipulated Order (D.S.C.

Pharmaceuticals 111

Pharmaceuticals Testimonials Trials Production 111