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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 11, 2023

BY WALKER LIVINGSTON, ESQ | NOV 29, 2023 6:48 PM EST AFFF suit and proposed settlements Beginning in 2019, the U.S. The case proceeded, and reached its first major settlement in early June 2023, when DuPont, Corteva, and Chemours reached an agreement to settle all claims for a combined $1.185 billion settlement.

Testimonials 40

Testimonials Regulations Compliance Treatment 40

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. A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising.

Disease 65

Disease Testimonials Production FDA 65

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. OCT 11, 2023 7:05 PM CDT What are PFAS? This overview will outline the various actions the EPA has taken to address PFAS.

Regulations 40

Regulations Production Packaging Treatment 40

Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

DECEMBER 21, 2023

Speaking of cold and darkness, it is now time for us to look back upon the results of drug and medical device litigation during 2023 and to select the ten worst decisions of the year. 122 (2023) ( here ). 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs.

FDA Approval 52

FDA Approval FDA Drugs Production 52

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.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

DECEMBER 28, 2023

Instead, an association, typically established through observational research with statistically significant results, was the starting point. 3d _-, 2023 WL 8711617 (S.D.N.Y. 18, 2023), is a worthy heir to the history above. 2023 WL 8711617, *2. Litig. , — F.

Testimonials 52

Testimonials FDA Science Drugs 52

Drug & Device Law

DECEMBER 20, 2023

Attorney’s office, where we knew nothing of billable hours, MDL case management orders, fancy office coffee machines, or an army of young lawyers available to help with research and drafting. Facteau , 2023 WL 8641918 (1st Cir. Cases brought under Title 21 bring us back to our days at the U.S. Such is the case with United States v.

FDA 52

FDA Trials Production Testimonials 52

Drug & Device Law

FEBRUARY 20, 2023

2023 WL 1192538 (Mag. 27, 2023), which we discussed here , addressed at length the plaintiff’s attempt to rely on “alternatives” that “existed,” but “were not yet cleared by the FDA for the purpose of treating” the plaintiff’s condition. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

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. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 11, 2024

3d , 2023 WL 2825871 (N.D. 3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). 2023) (“ AHM II ”). Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. FDA , 78 F.4th

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

AUGUST 24, 2023

June 14, 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.” This combination brings us to today’s case, MacSwan v. Merck & Co.

Testimonials 52

Testimonials International Treatment Production 52