Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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FDA Law Blog: Biosimilars

JULY 21, 2024

FDA — were a group of environmentally conscious interest groups that brought suit against FDA to better regulate the use some antimicrobials in livestock and poultry. In alleging that antibiotic use was a public health problem that FDA should regulate, the plaintiffs offered several testimonials from ostensibly affected people.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 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

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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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

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 25, 2024

The testimony of witnesses and the Senators themselves largely agreed on the designation, but diverged on questions of liability exemptions. How the agency plans to regulate PFAS via CERCLA In late 2021, the EPA published the PFAS Strategic Roadmap , which laid out the planned PFAS strategy for the agency between 2021 and 2024.

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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

Under Article III of the Constitution , a party must have “standing” to challenge a rule or law. They were not subject to any direct regulation by the FDA related to mifepristone. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote.

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The Pharma Data

MAY 13, 2021

I did find one article that caught my eye. Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. And it got to a point where I realized that this just wasn’t normal…. I started Googling all the stuff I was dealing with (LOL).

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The Pharma Data

MAY 13, 2021

scientific trials and regulations, modern medicine by. Just read and watch the testimonials for. Articles: MS Types: Different Types of MS |. More Articles on MS Types… MS Symptoms: Multiple Sclerosis Symptoms |. More Articles on MS Symptoms… MS Drugs: MS medicine |. details in public, I used actors.

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Drug & Device Law

FEBRUARY 11, 2024

The journal retracted the following three articles: Studnicki J., The first two of these articles were cited no fewer than six times in the District Court’s decision. Neither article, however, could have passed muster under Fed. FDA litigation that is now before the Supreme Court. We were hardly alone. Longbons T., Studnicki J.,

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Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. 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.

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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. Rather than examine the actual bases of those opinions, as Rule 702(b) required, Crockett waved the testimony through with the single observation that the expert claimed to have “conducted a “detailed review of the literature.”

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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.” Nor could Plaintiff fill that void by relying on expert testimony from other cases.

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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). The article stated that each of the thirty-three individuals had no known asbestos exposure other than talcum powder. That article has “junk science” red flags flying all over it. So Dr. Moline set out to fill that void.

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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.” Articles of Device (Acuflex; Pro-Med) , 426 F. 801.109(c). In the FDA regulatory context, United States v. Robinson , 2022 WL 614919, at *4 (citations omitted).

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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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