Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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The Pharma Data

MAY 14, 2021

Product Name: CarboFix. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. That stops the production of “new fat”….

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps.

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Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

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The Pharma Data

MAY 13, 2021

Product Name: Unblock My Hormones And Start Burning Fat TODAY With HB5. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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PLOS: DNA Science

APRIL 4, 2024

The products infiltrate the many folds and crevices of a vast human skinscape. ” 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. ” For everyone. ” Lady parts. .” ” Lady parts.

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The Pharma Data

MAY 14, 2021

Product Name: Fast Shingles Cure – The #1 Shingles Treatment Method Available. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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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?

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The Pharma Data

MAY 13, 2021

Product Name: Let's Quit Sugar With Audiobook – Let's Quit Sugar. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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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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Conversations in Drug Development Trends

MARCH 11, 2025

As these innovative therapies begin clinical trials in new patient communities, its essential to understand how to successfully adapt lessons and processes from oncology CAR T therapies into these studies. Moreover, these factors continue to be limiting even after marketing authorization is achieved.

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The Pharma Data

MAY 13, 2021

Product Name: Multiple Sclerosis MS Treatment eBook Cure By Dr. Gary M. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Payment can be.

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The Pharma Data

MAY 13, 2021

Product Name: Eat The Fat Off. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Spend a few years in trial and error testing.

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Drug & Device Law

MARCH 6, 2024

It’s getting harder and harder to get civil jury trial experience. Still, wouldn’t it be better if your trial judge had some sense of how these things really work?) For example, if the expert opines that our client’s product has a defective design, we will ask specific questions about the design process. But at least he got it.

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Drug & Device Law

MARCH 4, 2024

In re Onglyza (Saxagliptin) & Kombiglyze (Saxagliptin & Metformin) Products Liability Litigation , F.4th Onglyza Product Cases , 307 Cal. After the plaintiffs’ causation expert was hoist with her own petard in the initial Rule 702 decision, In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation , 26 F.

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Drug & Device Law

FEBRUARY 23, 2024

In In re Onglyza & Kombiglyze Products Liability Litigation , No. The FDA had asked the manufacturers to conduct a randomized controlled trial with multiple cardiac endpoints, which they did. Plaintiffs’ response to this was predictable: Leave it to the jury to “evaluate and weigh” the testimony.

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Drug & Device Law

JANUARY 15, 2024

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. 2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v.

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Drug & Device Law

DECEMBER 28, 2023

Many lawyers who at least dabble in product liability litigation have heard the term “Bradford Hill criteria.” 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.” We offer two examples.

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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

But this year, as bad as the bottom ten opinions we discuss below are, our sense is that they are somewhat overshadowed by even worse non-prescription medical product judicial malarkey. But even putting those goliaths aside, it’s an unpleasant enough job to chronicle the ten worst prescription medical product liability decisions of the year.

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Drug & Device Law

DECEMBER 20, 2023

The FDA took the position that such a 510(k) clearance would involve a combination drug/device product. After the verdict, the defendants filed post trial motions challenging the convictions as violations of the executives’ first amendment rights. The trial court refused to give such an instruction. Instead, it was no deal.

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Drug & Device Law

DECEMBER 12, 2023

As is the situation with most Lone Pine orders, this latest one was entered after the court’s “long-standing effort to bring [the other injury cases] to trial” failed. In re: Zostavax Products Liability Litigation , 2023 WL 8258533, *1 (E.D. A full expert report is not required at this time.

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Drug & Device Law

OCTOBER 18, 2023

In our recent ediscovery for defendants update , we highlighted two of the twenty-eight cases we included as the most important: In re Tasigna (Nilotinib) Products Liability Litigation , 2023 WL 6064308 (Mag. Nor was the trial court’s order compelling production so overly broad as to be an abuse of discretion. 3d 812 (N.J.

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Drug & Device Law

OCTOBER 11, 2023

Rule 16 : Amend to add privacy and cybersecurity as topics for prompt pre-trial consideration. In our product liability sandbox, medical information is the most commonly encountered form of confidential information, but the LCJ proposal doesn’t really address it. The court in Bell v. American International Industries , 627 F.

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Drug & Device Law

SEPTEMBER 25, 2023

Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over. See In re Bair Hugger Forced Air Warming Devices Products Liability Litigation , F. Not surprisingly the once and future exclusion of the plaintiffs’ expert testimony loomed large in this ginned-up dispute. See Gareis v. 4th 812 (8th Cir.

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Drug & Device Law

JULY 24, 2023

Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.” Prescription medical product liability litigation has existed for decades.

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Drug & Device Law

JUNE 23, 2023

But, because this litigation (like most product liability MDLs) only exists because of lawyer solicitation, such solicitation dredges up many plaintiffs who sat on their hands for much longer than the aforesaid six month period. at *14; and plaintiff King from Oklahoma, id. at *14, 94, and the other two we can’t tell). at *34-35.

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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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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

MARCH 23, 2023

were proximately caused by the erosion of the mesh product.” Plaintiff also argued that the trial court should have allowed her to offer expert causation testimony from the explanting physician, thus raising an issue of material fact to defeat summary judgment. 2d 624, 631 (E.D.N.C.

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. Some discussion of preemption of state “stop selling” actions outside of product liability are here , here , and here.]

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Drug & Device Law

MARCH 9, 2023

Defense trial lawyers with a lot of, er, gumption have been known to rest at the end of plaintiff’s case without presenting any witnesses. More generally, a defendant can rely on the jury to reject plaintiff’s expert’s testimony, especially when aided by effective cross-examination. Eberhart , 977 F.2d 2d 673 (1st Cir.

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Drug & Device Law

FEBRUARY 20, 2023

Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim. at 237-38. As a result, appellee was prohibited by federal law from employing either of these [alternatives].

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Drug & Device Law

FEBRUARY 8, 2023

The same was true with Judge Canby on the Ninth Circuit.) The bottom line is that an adverse commercial or (sigh) product liability case can be difficult to reverse on appeal, and that is particularly true if you are grousing about factual and evidentiary issues. We mourned this reality after reading Bayless v. That’s fine with us.)

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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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