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.

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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?

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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. TSCA also focuses on regulating chemical substances which may present an unreasonable risk of injury to health or the environment.

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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.

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Agency IQ

JUNE 17, 2024

And even if not, the doctor must participate in the medical treatment that facilitates an abortion. The Doctors allege that being made to provide this treatment conflicts with their sincerely held moral beliefs and violates their rights of conscience. They were not subject to any direct regulation by the FDA related to mifepristone.

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The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. So what’s the fix here?

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The Pharma Data

MAY 13, 2021

Product Name: Multiple Sclerosis MS Treatment eBook Cure By Dr. Gary M. Click here to get Multiple Sclerosis MS Treatment eBook Cure By Dr. Gary M. Multiple Sclerosis MS Treatment eBook Cure By Dr. Your doctor may be putting on a brave face, but the. They try every known cure, treatment and medically accepted idea — yet.

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The Pharma Data

MAY 13, 2021

You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. Testimonials are not necessarily representative of all of those who will use our products. A survey of the opinions of obesity experts on the causes and treatment of obesity.

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Agency IQ

JULY 28, 2023

October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

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Drug & Device Law

JANUARY 15, 2024

It is not evidence of the underlying attributes of the product that make it compliant with regulations or standards, which is presumably admissible subject to the ordinary Rules of Evidence. “To assign liability for no reason other than the ability to pay damages is inconsistent with our jurisprudence.” Bell Sports, Inc. , 2d at 1013-14.

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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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Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The decision simply ignored the minuscule increased risk, and didn’t compare it to the risks of any alternative treatment – or to the risks of leaving the disease, diabetes, untreated. FDA , 78 F.4th 4th 210 (5th Cir.

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Drug & Device Law

AUGUST 24, 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.” at *3 (internal quotation marks and citations omitted). at *8-10. at *14 (citation omitted).

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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.

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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.

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Drug & Device Law

FEBRUARY 20, 2023

Because mesh such as [plaintiff’s claimed alternatives] were not cleared by the FDA for treatment of stress [plaintiff’s condition] at the time of [her] surgery, they were not legally available at the time and, in this Court’s view, they do not qualify as safer alternative designs as a matter of law. Baksic relied on Pizzitola v.

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Drug & Device Law

JUNE 1, 2022

May 25, 2022), the Wisconsin Court of Appeals reversed a lower court’s granting of an injunction compelling treatment with ivermectin. By contrast, the defendant submitted a doctor affidavit that discussed the patient’s history and treatment plan in detail. Aurora Healthcare , 2022 WL 1657559 (Wisc.

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Drug & Device Law

FEBRUARY 21, 2022

The defendant sought Pence’s exclusion because “she is not qualified due to her lack of education, experience, or specified knowledge about the regulation of medical devices, specifically the defendants’ mesh.” Plaintiff’s] argument that [her] testimony has been admitted in other cases is not persuasive. Coloplast Corp.

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