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

JUNE 29, 2023

What We Expect the FDA to do in July 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

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

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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

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 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

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 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

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

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

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

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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