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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Government FDA Biosimilars Regulations 40

FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. 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. 1, 2023 ( 02:38:46 ).

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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. N Engl J Med.

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Disease Production Testimonials Science 52

The Pharma Data

MAY 13, 2021

Then these hormones can’t regulate your metabolism like they should…. Additionally, in a 2018 study, published in the journal Phytotherapy Research…. Along with the amount of estrogen-regulating DIM that he added as well. It was like the floodgates burst wide open…. And the fat just came pouring off. So what’s the fix here?

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Production Packaging Doctors Research 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.

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Testimonials Trials Science Government 59

Drug & Device Law

NOVEMBER 28, 2022

2018) (Etminan); Gerke v. 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. II) , 341 F.

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Drug & Device Law

MARCH 28, 2022

2018 WL 3649714 (S.D. April 19, 2018). 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. High on the list was Tsao v. In Sadler v.

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Testimonials FDA Regulations Production 59