2014, Regulations and Testimonials - Drug Discovery Digest

Article FDA Thank You New FDA guidance on addressing misinformation under White House review

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New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of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

FDA

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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

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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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

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.

FDA

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Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

MAY 13, 2021

Testimonials are not necessarily representative of all of those who will use our products. Some of our testimonials are provided by customers who have received promotional offers in exchange for their participation. The testimonials displayed are given verbatim except for correction of grammatical or typing errors. 2011.01.029.

Disease

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

FDA Science Regulations Production

Unblock My Hormones And Start Burning Fat TODAY With HB5

The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. While in a 2014 study published in the journal Biological Trace Elements Research…. Which is a finding that’s backed up by another 2014 human study…. Along with the amount of estrogen-regulating DIM that he added as well. So what’s the fix here?

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50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

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

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Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

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. We] “borrow” the OSHA regulation for use as evidence of the standard of care owed to plaintiff. Coffing Hoist Division , 528 A.2d 2d 590 (Pa.

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Generic Causation Experts Excluded In Sweeping Ruling From The Acetaminophen MDL

Drug & Device Law

DECEMBER 28, 2023

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.” including all neurodevelopmental issues to get an increased risk in a study that was only designed to look at ASD).)

Testimonials

Testimonials FDA Science Drugs

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives.

FDA

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On Expert “Adulteration” and “Misbranding” Opinions

Drug & Device Law

MARCH 28, 2022

A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.

Testimonials

Testimonials FDA Regulations Production

Drug Discovery Digest

Article FDA Thank You New FDA guidance on addressing misinformation under White House review

Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Let's Quit Sugar With Audiobook – Let's Quit Sugar

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Unblock My Hormones And Start Burning Fat TODAY With HB5

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Generic Causation Experts Excluded In Sweeping Ruling From The Acetaminophen MDL

The FDA and Feasible Alternative Designs

On Expert “Adulteration” and “Misbranding” Opinions

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