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. Of note: A government shutdown would likely delay or cancel some of the events listed below.

FDA

Agency IQ

MARCH 25, 2024

The testimony of witnesses and the Senators themselves largely agreed on the designation, but diverged on questions of liability exemptions. The act establishes a liability scheme to authorize the federal government to clean up contaminated sites in the country and force potentially responsible parties (PRPs) to pay for those cleanup costs.

Testimonials

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. Government shutdown: At present, the FDA has appropriated funding through January 19.

FDA

Agency IQ

JUNE 17, 2024

As reported by POLITICO , “The decision — if allowed by the Supreme Court to take effect — would roll back actions the federal government has taken since 2016 to make the pills more accessible, including rules allowing online ordering, mail delivery, and pharmacy dispensing of the drugs. Read AgencyIQ’s analysis of that case here. ]

FDA

The Pharma Data

MAY 13, 2021

That took me through the dark underbelly of the multi-billion dollar weight loss industry controlled by government and elite societies…. Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. But might very well save your life too.

Production

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

Drug & Device Law

FEBRUARY 20, 2023

Yet another vaccine case addressed at length the reasons why viable design alternatives for products governed by the FDCA must be limited to those that the FDA has allowed onto the market. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. 2d 839, 851 (N.Y. Baksic relied on Pizzitola v.

FDA

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Polansky v. 3d 239 (Cal.

Testimonials

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). Moline has given testimony in many other cosmetic talc cases” while keeping the (at least potentially) false premise of her article secret supported disclosure of the contrary evidence. 11-17 (Jan. It got worse. quoting 45 C.F.R.

Testimonials

Drug & Device Law

DECEMBER 20, 2023

Nevertheless, according to the government, the company went ahead and marketed the device for the unapproved steroid delivery application. 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.)

Trials

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance

Drug & Device Law

JANUARY 24, 2022

Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Valsartan Testimony ¶3. PPI ¶11 (participants must “comply with any government law, regulation or guidance regarding public health and safety during the COVID-19 pandemic”). All depositions. . . H/C ¶1(A); accord Zantac ¶22. Onglyza , ¶3; H/C ¶1(E).

Pharmaceuticals

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. While the VA provided some discovery, it denied the large majority of the requests under their Touhy regulations.

Regulations

Drug & Device Law

MARCH 4, 2022

702 – that they were not qualified, their testimony was not based on sufficient facts or data, their methodologies were not reliable, and they did not reliably apply their methodologies to the facts of the case. their testimony does not present a genuine issue of medical fact.” Motion to Exclude Experts. emphasis in original).

Testimonials

Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” That testimony was contrary, not only to the common-law cases discussed in our prior posts , but also flatly contradicted §801.109(c). 801.109(c).

Testimonials