The Pharma Data

MAY 14, 2021

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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

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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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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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

OCTOBER 20, 2023

PFAS are found in drinking water, consumer products such as textiles, cookware, and personal care products, and firefighting foam. 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.

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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. AgencyIQ October 1 Nitrosamine testing due to FDA.

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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. This is what OIRA is currently reviewing.

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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. They are used in cleaning products, cookware, leather, paint, and wire insulation. The hearing also featured questions from BEN CARDIN (D-Md.), DEBBIE STABENOW (D-Mich.), PETE RICKETTS (D-Neb.),

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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 13, 2021

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Agency IQ

JUNE 17, 2024

They were not subject to any direct regulation by the FDA related to mifepristone. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote. While other parties may still sue the FDA over its regulation of mifepristone, the Court’s decision is important for the FDA.

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FDA Law Blog: Biosimilars

MARCH 24, 2025

In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled. Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use. The hearing is currently on hold pending an appeal by several of the parties.

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The Pharma Data

MAY 13, 2021

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Through relationship-building and increased engagement, regulators aim to improve their understanding of the ‘lived experience’ of patients with rare diseases and hear their top concerns. For example, Voice of the Patient and Patient-Focused Drug Development meetings are focused on one disease or a group of similar diseases.

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The Pharma Data

MAY 13, 2021

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Drug & Device Law

FEBRUARY 16, 2024

5, 2024) serves up some nice defense nuggets applying the Washington Product Liability Act (WPLA) and refusing to let a sham affidavit create a fact issue. Plaintiffs provided testimony from that physician suggesting that he would have changed his prescribing decision if presented with plaintiffs’ proposed warning language. Allied Mut.

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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.37 702 in product liability litigation. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v.

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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 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. 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. Norfolk Southern Railway Co. ,

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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. The motions relied “on an emerging body of law protecting commercial speech that promotes off-label uses of medical products.” The plan was to pursue a later, second 510(k) clearance for the steroid delivery function.

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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. Plaintiff brought a putative class action against the manufacturer of powdered creamer products alleging its nutrition labels inaccurately described the serving size. So discovered the plaintiff in Gwinn v. Laird Superfood, Inc.,

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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

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

MAY 30, 2023

In prescription medical product liability litigation, especially in MDLs and mass torts, that means defendants are more likely than not to run into plaintiffs who received at least some medical care from the Department of Veterans Affairs (“VA”). There are approximately 1.4 at *21-22.

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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

DECEMBER 5, 2022

30, 2020), decided an action filed by the California attorney general that had essentially converted the allegations that product liability plaintiffs had been making against the defendants’ pelvic mesh into the basis for a statewide civil action under certain California consumer protection statutes. 2020 WL 603964, at *1. and actual injury.

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Drug & Device Law

NOVEMBER 28, 2022

Our rogues’ gallery contained: In In re Zofran (Ondansetron) Products Liability Litigation , 392 F. 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 3d 179, 181-87 (D. II) , 341 F.

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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 defendant proposed to bring in an FDA expert who would explain to the jury how the vaginal mesh product had been cleared through FDA’s 510(k) process.

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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.” Johnson & Johnson Vision Products, Inc. , 801.109(c). The most notable application of this exception was in Ellis v. Bard, Inc. , 3d 1272 (11th Cir. 3d at 1286.

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Drug & Device Law

MARCH 28, 2022

March 2, 2022), the court held that the expert “cannot take the final step of opining that the product was ‘misbranded’ or ‘adulterated,’ as these are impermissible legal conclusions.” Polypropylene Hernia Mesh Products Liability Litigation , 2021 WL 3286439 (S.D. In Robinson v. Ethicon, Inc. 2022 WL 614919 (S.D. See In re Davol, Inc./C.R.

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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

11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.” since] every case must be decided on its own merits.

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Drug & Device Law

JANUARY 24, 2022

In re Valsartan, Losartan, & Irbesartan Products Liability Litigation , MDL No. In re Onglyza (Saxagliptin) & Kombiglyze XR (Saxagliptin & Metformin) Products Liability Litigation , MDL No. In re Zantac (Ranitidine) Products Liability Litigation , MDL No. Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2.

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