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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

MARCH 1, 2024

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). According to a FY 2022 report , the program had $13.1

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Government FDA Biosimilars Regulations

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. 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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Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

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FDA Science Biosimilars Regulations

Analysis Chemical Thank You Overview of the U.S. regulation of PFAS

Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. to include devices.

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After a Hiatus, the BLOCKING Act is Back!

FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

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. As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Bonta , 85 F.4th

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Mixson Somewhat Mixed, But We’ll Take It

Drug & Device Law

NOVEMBER 1, 2022

16, 2022) (“ Mixson I ”), and Mixson v. 2022 WL 7581737 (N.D. 23, 2022) (“ Mixson II ”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results. 2022 WL 4364153, at *2. 2022 WL 4364153, at *2. Mixson I , 2022 WL 4364153, at *5. Bard, Inc. ,

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Too Much “Weight Not Admissibility,” But a Good Result, in D. Minn. Mesh Decision

Drug & Device Law

JULY 25, 2022

A package of hot dog rolls is labeled “Hamburger Buns.” 2022 WL 2806390 (D. July 18, 2022), including the ultimate result. Cantrell , 2022 WL 2806390 at *1. B]ecause the opinions in [the expert’s] report pertain only to transvaginal implantation, [the] testimony would be unhelpful to a jury. Coloplast Corp.

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The Medical Device Labeling Exception for “Commonly Known” Hazards

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. 2022 WL 970681 (N.D. 801.109(c).

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Confident Learned Intermediaries Defeat Warning Causation

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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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

Somatics, LLC , 2022 WL 989469 (9th Cir. April 1, 2022) (the companion case to this ). The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Plaintiff] has not identified any testimony from [the prescriber] that. . . at *3 (emphasis original). 3d 1223 (11th Cir.

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Pelvic Mesh Remand Cases Continue To Stall

Drug & Device Law

MAY 12, 2022

2:20-cv-02477-AWI-BAK, 2022 U.S. 29, 2022), the judge considered a motion to reconsider in connection with the exclusion of certain opinions from the plaintiff experts in a pelvic mesh remand case. Enborg , 2022 U.S. Their refusal to accept those impacts without a fight can lead to some surprising postures. In Enborg v.

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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Webinars

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Analysis Chemical Thank You Overview of the U.S. regulation of PFAS

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

After a Hiatus, the BLOCKING Act is Back!

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Mixson Somewhat Mixed, But We’ll Take It

Too Much “Weight Not Admissibility,” But a Good Result, in D. Minn. Mesh Decision

The Medical Device Labeling Exception for “Commonly Known” Hazards

Confident Learned Intermediaries Defeat Warning Causation

Unimpressed Learned Intermediaries Defeat Warning Causation

Pelvic Mesh Remand Cases Continue To Stall

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