FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. For generic drug manufacturing facilities specifically, the numbers are 63% and 87%.

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The Pharma Data

NOVEMBER 24, 2020

Dr. Paul Hunter, of the city of Milwaukee health department and a voting member of the committee, said the testimonials of the first batches of people who get a COVID-19 vaccine could be crucial to wider acceptance. Though talk of two highly effective vaccines came this week, they will not be widely available until spring of 2021.

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Agency IQ

JUNE 16, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. Circuit vacated the final rule in 2021. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

OCTOBER 27, 2023

Circuit vacated the final rule in 2021. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. FDA finalized a ban on these devices in 2020, but the D.C. to include devices.

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Agency IQ

JULY 28, 2023

First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Agency IQ

MARCH 25, 2024

The testimony of witnesses and the Senators themselves largely agreed on the designation, but diverged on questions of liability exemptions. How the agency plans to regulate PFAS via CERCLA In late 2021, the EPA published the PFAS Strategic Roadmap , which laid out the planned PFAS strategy for the agency between 2021 and 2024.

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The Pharma Data

MAY 16, 2021

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The Pharma Data

MAY 14, 2021

© 2021 Copyright: ToxicMetalFlush.com. ClickBank’s role as retailer does not constitute an endorsement, approval or review of these products or any claim, statement or opinion used in promotion of these products.

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The Pharma Data

MAY 14, 2021

© 2021 Copyright: 7DayFatMeltaway.com. ClickBank’s role as retailer does not constitute an endorsement, approval or review of these products or any claim, statement or opinion used in promotion of these products. 7 Day Fat Meltaway Plan – Video is backed with a 60 Day No Questions Asked Money Back Guarantee.

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Agency IQ

OCTOBER 20, 2023

EPA’s response to PFAS On April 27 2021, the EPA Administrator Michael Regan established an EPA Council on PFAS to understand and address the risks associated with PFAS. The next round will be reported in from June 1 to September 30, 2024 and will comprise data from 2020, 2021, 2022, and 2023.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. to include devices.

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The Pharma Data

MAY 15, 2021

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Agency IQ

JUNE 17, 2024

(“Finally, many doctors offered testimony that, as a result of the 2021 Non-Enforcement Decision, more women will suffer serious adverse events,” the court wrote. As such, they have associational standing to challenge this action.”)

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Agency IQ

DECEMBER 1, 2023

Circuit vacated the final rule in 2021. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. FDA finalized a ban on these devices in 2020, but the D.C. to include devices.

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Drug & Device Law

FEBRUARY 20, 2024

Nor did the court find persuasive cases in which other courts left open the possibility that the treating physician may have at some time reviewed the IFU because here the surgeon’s testimony left no room for doubt. He’d never read the IFU; never seen it.

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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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Drug & Device Law

JANUARY 15, 2024

2021), aff’d by an equally divided court , 2023 WL 8859656 (Pa. 2021 WL 2656690, at *6 (3d Cir. June 24, 2021). 2021 WL 9950511 (3d Cir. 10, 2021) (granting unopposed motion to dismiss pursuant to settlement). However, Pennsylvania’s intermediate appellate court decided otherwise in Sullivan v. Werner Co. ,

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Drug & Device Law

JANUARY 9, 2024

Like when written discovery responses say one thing, medical records say the same thing, plaintiff’s deposition testimony is also the same, but a post deposition affidavit says something completely different. 9, 2023). Plaintiff had an IVC filter implanted in 2013 and filed suit in 2021. And the court in Stanford v.

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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 26, 2023

Testimony by expert witnesses. First, the Committee found it necessary to “emphasize” both the court’s role and the burden of proof. “[E]xpert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in the rule.”

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Drug & Device Law

DECEMBER 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). Also, given other recent rulings in Zostavax ( 2022+10 ; 2021+19 ), the remaining plaintiffs in Zostavax aren’t likely to profit from that mistake. Good riddance.

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Drug & Device Law

NOVEMBER 7, 2023

The prescriber’s testimony in this case is key. Her condition worsened in 2021, causing her physician to switch her to defendants’ drug. Without that, plaintiff does not have causation. Without causation, all his other arguments are irrelevant. At the time he treated plaintiff’s mother, he used three mood stabilizers.

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Drug & Device Law

OCTOBER 9, 2023

In fact, Zostavax has made our year-end “best of” lists twice, in 2022 (#10) and 2021 (honorable mention). The MDL Court also entered summary judgment in 2021 against five bellwether plaintiffs after excluding all their experts on Rule 702 grounds. See In re Zostavax (Zoster Vaccine Live) Products Liability Litigation , 2022 U.S.

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Drug & Device Law

SEPTEMBER 25, 2023

702 standards for expert admissibility – a decision that we consider the worst drug/device decision of 2021. Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over. Not surprisingly the once and future exclusion of the plaintiffs’ expert testimony loomed large in this ginned-up dispute.

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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. 3d , 2021 WL 68997, at *23 (Ala. BASF Corp. ,

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Drug & Device Law

FEBRUARY 27, 2023

As we’ve discussed, those amendments reiterate what had always been (at least since 2000) the Rule’s requirements for analyzing the admissibility of expert witness testimony. The Committee concluded that in a fair number of cases, the courts have found expert testimony admissible even though the proponent has not satisfied the Rule[‘s]. . .

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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. 2021 WL 5054648 (S.D. 1, 2021), which likewise rejected non-FDA-cleared alternatives. Johnson & Johnson , 2021 WL 3719554, at *2 (S.D. His testimony is thus irrelevant and inadmissible. 2021 WL 4819443, at *4 n.2

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Drug & Device Law

JANUARY 6, 2023

In opposition, the plaintiff argued that a “new cause of action ha[d] arisen” out of the defendant’s “defect” admissions to the FDA about the product’s battery life and an April 2021 recall of the product. Reddick , 2022 WL 17903708 at *3. .

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Drug & Device Law

DECEMBER 27, 2022

Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. In the Zantac MDL, the plaintiffs’ causation problems were plainly visible on the horizon, as we mentioned in our post last year about the Zantac ruling on medical monitoring, In re Zantac (Ranitidine) Products Liability Litigation , 546 F.

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Drug & Device Law

SEPTEMBER 9, 2022

For instance, plaintiffs in the vast majority of cases know that they will need evidence from a prescribing physician, testimony or affidavit for summary judgment and testimony for trial. Sexton , 2021 WL 4138399, at *4; Huskey , 29 F.Supp.3d 2021) (citations as in the original). 3d 736 at 743. 3d 691, 702 (E.D.

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Drug & Device Law

JULY 27, 2022

2021 WL 1178547 (D. March 26, 2021), for example. 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. Not all of the cases are brand-spanking new and not all are wonderful. Consider Wood v.

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Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

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Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” 2021) (applying Louisiana law). at *3 (emphasis original). Robins Co. ,

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Drug & Device Law

APRIL 18, 2022

fully briefed in early 2021, which will hopefully ? The surgeon’s testimony supported two grounds for non-causation: lack of reliance, and that a warning would not have changed how the prescription product was used. 2021 WL 1200038, at *2 (C.D. Teleflex Med. and finally ? See Munoz v. American Medical Systems, Inc.

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Drug & Device Law

MARCH 28, 2022

Polypropylene Hernia Mesh Products Liability Litigation , 2021 WL 3286439 (S.D. 1, 2021), which held that “no expert. . . Polypropylene Hernia Mesh Products Liability Litigation , 2021 WL 3617152, at *2 (S.D. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach. See Tyree v.

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Drug & Device Law

FEBRUARY 28, 2022

2021), Rule 702 decision, was that one of the inadmissible experts had relied on “search[ing] it on Google” as the basis for some of his junk opinions. 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.

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Drug & Device Law

FEBRUARY 25, 2022

Here’s a snapshot of some of PLAC’s recent activity just from 2021 and early 2022: Drug/Device Issues. 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. filed March 4, 2021). Cartee , No. SC20607 (Conn.

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