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?

Government 40

Government FDA Biosimilars Regulations 40

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

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.

FDA 40

FDA Science Regulations Production 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 83

Disease Production Testimonials FDA 83

FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. 1, 2023 ( 02:38:46 ). AG Garland opined during his confirmation that he did not think it the best use of DOJ’s limited resources to prosecute those who are complying with the laws in those states that have legalized marijuana and are effectively regulating it.

Testimonials 45

Testimonials Regulations Compliance Drugs 45

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

FEBRUARY 11, 2024

3d , 2023 WL 2825871 (N.D. 3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). 2023) (“ AHM II ”). See AHM I , 2023 WL 2825871, at *4 n.9 See AHM I , 2023 WL 2825871, at *4 n.9 See Alliance for Hippocratic Medicine v. See Alliance for Hippocratic Medicine v. FDA , 78 F.4th 4th 210 (5th Cir. Studnicki J.,

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

JANUARY 15, 2024

2021), aff’d by an equally divided court , 2023 WL 8859656 (Pa. 22, 2023) (“ Sullivan I ”), another decision not involving prescription medical products. 2023 WL 8859656, at *9 (Pa. 22, 2023) (Opinion Announcing the Judgment of the Court (“OAJC”)). OAJC, 2023 WL 8859656, at *11. Werner Co. , 3d 730 (Pa.

Compliance 52

Compliance Government FDA Compliance Production 52

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 Drugs FDA Vaccine 105

Drug & Device Law

DECEMBER 28, 2023

3d _-, 2023 WL 8711617 (S.D.N.Y. 18, 2023), is a worthy heir to the history above. 2023 WL 8711617, *2. In a paraphrase of the testimony of a difficult opposing epidemiology expert who passed away recently, “you have to say what you will do and then do what you say.” Litig. , — F.

Testimonials 52

Testimonials FDA Science Drugs 52

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

DECEMBER 20, 2023

Facteau , 2023 WL 8641918 (1st Cir. Despite the chorus of criticism of recent Congressional testimony by a trio of tone-deaf college presidents, there really is a valid, if sometimes difficult, distinction between speech and conduct.) Such is the case with United States v. Could such “notice” have a chilling effect? Yes, of course.

Trials 52

Trials FDA Production Testimonials 52

Drug & Device Law

SEPTEMBER 12, 2023

Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic. There are also FDA regulations that state that for a powder, the serving size must contain a “reference amount” of 2 grams. While consumers don’t have to adhere to FDA regulations in measuring their servings, the manufacturer does.

FDA 59

FDA Regulations Testimonials Packaging 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

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

MAY 30, 2023

Which means they are also familiar with Touhy regulations and the frequency with which those regulations are used to deny requests for medical records and depositions in civil litigation. United States VA , 2023 U.S. May 16, 2023). The case is Schroeder v. LEXIS 85835 (D.

Regulations 59

Regulations Production Testimonials Government 59

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