Agency IQ

MARCH 1, 2024

In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. Notably, this explanation of what “excepted staff” does is different in both version of the 2024 contingency plan than what appeared in the 2023 contingency plan. What is happening now?

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Agency IQ

DECEMBER 11, 2023

In addition, the District of South Carolina will hold an additional final fairness hearing on February 2, 2024, to determine whether the 3M settlement should be certified as a class for the purposes of the settlement and whether the proposed settlement is “fair, reasonable, and adequate.”

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. 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. fit in this definition.

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Agency IQ

JUNE 29, 2023

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. OIG claims a review will be complete in 2024. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November. Review to take place within 21 days. to include devices.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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PLOS: DNA Science

APRIL 4, 2024

” 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. It debuted in January 2024 , but the company has been around since 2015. ” Lady parts. .” An objective assessment of odor would be nice.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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Agency IQ

JUNE 17, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JUN 13, 2024 5:57 PM CDT Background: What is standing, and why is it important to the FDA? Finally, many doctors offered testimony that, as a result of the 2021 Non-Enforcement Decision, more women will suffer serious adverse events,” the court wrote.

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Agency IQ

OCTOBER 20, 2023

The next round will be reported in from June 1 to September 30, 2024 and will comprise data from 2020, 2021, 2022, and 2023. The rule was planned to be released in August 2023, but this was moved back to February 2024. The EPA plans to release the final version of the PFAS NPDWR most likely in January 2024.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

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FDA Law Blog: Biosimilars

NOVEMBER 26, 2024

44,597 (May 21, 2024). No witness testimony will be offered nor received on Monday. Houck — Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III.

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Perficient: Drug Development

DECEMBER 18, 2024

React 19 has officially been released as a stable version on December 5, 2024. Example: Imagine a component hierarchy: <CourseWrapper> <CourseList /> <Testimonials /> </CourseWrapper> Lets assume all three components CourseWrapper , CourseList , and Testimonials are making individual network calls.

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Codon

JUNE 2, 2024

In a testimony in front of the U.S. ” Asimov Press (2024). While the use of inbred mice was initially constrained to research on the genetics of implanted tumors, the research applications of the lab mouse expanded greatly following a 1938 grant from the newly established National Cancer Institute. as it is possible to produce.

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Conversations in Drug Development Trends

MARCH 11, 2025

Current CAR T Landscape & Growth Trends CAR T therapies are witnessing an impressive surge of growth, with 2024 marking a record number of these studies. Tahseen Mozaffar of UC Irvine in an on-demand webinar, Expanding CAR T Beyond Oncology: Medical, Operational & Practical Considerations.

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Clinical Trials Therapies Trials Treatment 40

Agency IQ

JULY 28, 2023

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. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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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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Drug & Device Law

MARCH 4, 2024

4th , 2024 WL 577372, at *7 (6th Cir. Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” 2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been found inadmissible. . .,

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Drug & Device Law

FEBRUARY 23, 2024

22-6078, 2024 WL 577372 (6th Cir. 13, 2024) (to be published in F.4th), Plaintiffs’ response to this was predictable: Leave it to the jury to “evaluate and weigh” the testimony. The Sixth Circuit has now joined the chorus. In In re Onglyza & Kombiglyze Products Liability Litigation , No.

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Drug & Device Law

FEBRUARY 21, 2024

Our abiding skepticism about multidistrict litigations (MDLs) is redeemed — a little — by the recent decision in In re CPAP , 2024 U.S. The court tells us that “Plaintiffs’ counsel explained there will be no medical records diagnosing a subcellular injury but there will be expert testimony.” LEXIS 25528 (W.D.Pa. We bet there will.

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Testimonials 52

Drug & Device Law

FEBRUARY 20, 2024

2024 WL 385108 (S.D. Nor did the court find persuasive cases in which other courts left open the possibility that the treating physician may have at some time reviewed the IFU because here the surgeon’s testimony left no room for doubt. Sometimes the intersection of the law and the facts are simply undeniable.

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Drug & Device Law

FEBRUARY 16, 2024

2024 WL 416848 (W.D. 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. If accepted, the testimony may have altered the court’s analysis in the second motion for summary judgment. We blogged about that decision here.

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Drug & Device Law

JANUARY 19, 2024

2024 WL 99542 (D. 8, 2024), continues that positive trend. at *2 (we’ve previously posted that such testimony is insufficient to establish causation ). Things improved when the court began addressing causation at summary judgment , and pretty soon cases were falling like dominoes. Today’s decision from the MDL, Williams v.

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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. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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