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. FDA is also due to revise 24 other guidance documents at that time.

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Agency IQ

DECEMBER 11, 2023

Cities have cited low detections of PFAS as well as the expectation that payments would be too low to fund remediation efforts to bring the city or municipality into compliance with future state or federal water regulations for PFAS. On November 27, 2023, the La Crosse Common Council (WI) voted unanimously to opt out of the settlement.

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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Agency IQ

OCTOBER 20, 2023

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. TSCA also focuses on regulating chemical substances which may present an unreasonable risk of injury to health or the environment.

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

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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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Agency IQ

JULY 28, 2023

It’s also possible that some of FDA’s commitments – and especially things like new guidance documents – might get delayed later into October. That’s because significant guidance documents typically require review and approval by the White House’s Office of Information and Regulatory Affairs (OIRA) prior to publication.

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Drug & Device Law

DECEMBER 20, 2023

By contrast, Facteau involved medical device corporate executives, and the record contained considerable non-speech evidence (internal corporate documents, regulatory history, sales rep training and experience, surgeon training). In other words, the gist of the Caronia case really does seem to have been based on protected speech.

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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.

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Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). Upon learning of the production of this document, plaintiff and her counsel freaked. Document to be destroyed and not disseminated in this case or any other forum. 11-17 (Jan. It got worse. This effort largely failed.

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Drug & Device Law

JANUARY 24, 2022

Remote depositions are most often used for relatively brief examinations that do not involve numerous documents, but may also be used to reduce travel costs. . . . Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Valsartan Testimony ¶3. Through use of. . . Manual for Complex Litigation (4th), at 86-87.

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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

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. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. ,

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Drug & Device Law

FEBRUARY 21, 2022

The defendant sought Pence’s exclusion because “she is not qualified due to her lack of education, experience, or specified knowledge about the regulation of medical devices, specifically the defendants’ mesh.” Nor could Pence opine on “the knowledge of the defendants” using internal documents Id. 2022 WL 409638 (N.D.

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