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

Agency IQ

MARCH 1, 2024

history was in 2018-2019, totaling 35 days. It’s worth noting here that according to one drug sponsor , their application submitted “the day before the shutdown started” in 2018 was not able to be reviewed during the “lapse” period, meaning there is some sort of pre-shutdown deadline. What are the impacts for regulated industry?

Government

Government FDA Biosimilars Regulations

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

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.

Disease

Disease Production Testimonials Science

Package | Prasara Yoga

The Pharma Data

MAY 14, 2021

Nothing accessed is to be interpreted as a general or specific recommendation for a specific treatment plan, product, exercise regimen or course of action. individual ailment, treatment or problem. All testimonials on this site are real. © 2018 RMAX.tv Consult your doctor before using any exercise, device, or program.

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Natural Penis Enlargement | The PE Bible

The Pharma Data

MAY 16, 2021

I’m going to show you actual video testimonials from real users. I’m not a fool and I’m certainly not taking you for a fool… I insist on video and audio testimonials so you experience the results with your own eyes and ears. Copyright 2018, PE BIBLE. Most don’t want to share proof.

Testimonials

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Unblock My Hormones And Start Burning Fat TODAY With HB5

The Pharma Data

MAY 13, 2021

Additionally, in a 2018 study, published in the journal Phytotherapy Research…. 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. Which was also randomized, placebo-controlled, and double-blind….

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Article FDA Thank You Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Agency IQ

JULY 13, 2023

In June, the House Committee on Energy and Commerce (E&C) held a hearing on the House’s initial proposal , featuring testimony from witnesses and some legislative proposals for discussion. Congress is already working on the reauthorization process.

FDA

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Another RICOdiculous Decision

Drug & Device Law

JULY 24, 2023

Yet what the plaintiffs were claiming is that, despite Actos’ undisputed effectiveness as a diabetes treatment, no TPP in the country would have purchased it for that purpose because of the 3/10,000 bladder cancer increased risk. See , e.g. , In re Thalomid & Revlimid Antitrust Litigation , 2018 WL 6573118, at *4 (D.N.J.

Testimonials

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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

Testimonials Trials Science Government

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. Medrano , 28 S.W.3d

Testimonials

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Guest Post – Curling Up With a Good Reasonable Alternative Design Opinion

Drug & Device Law

JANUARY 28, 2022

At issue in Fajardo was the defendant’s vaginal implant for the treatment of stress urinary incontinence, a mesh sling designed to be placed using a transobturator approach. 3:14-cv-00549 (VLB), 2018 WL 1525709, *25 (D. March 28, 2018)) (quotations omitted). The jury returned a defense verdict. newsflash! ) Flowserve US, Inc.

Testimonials

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. That oncologists prescribing lifesaving standard-of-care treatment in the face of “aggressive cancer” are not impressed by a risk of – permanent hair loss – is not surprising. at *3 (emphasis original). 2d 806, 817 (5th Cir.

Testimonials

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Another Dismissal in the Birmingham Hip MDL

Drug & Device Law

JANUARY 19, 2024

We’ve been posting about decisions from In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation , MDL 2775, since 2018. Its preemption ruling on defendant’s motion to dismiss made the list of ten worst decisions from 2018 , and a subsequent preemption decision reflected more MDL madness.

Testimonials

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Taxotere Timing Troubles Persistently Plague Plaintiffs

Drug & Device Law

JUNE 23, 2023

Specifically, plaintiffs have defined their injury as being hair loss that persists more than six months after their cessation of treatment with the defendant’s cancer chemotherapy drug. 2018) (all substantive law); McCarrell v. Her “injury” thus existed as of December 30, 2007, six months after her treatment was completed.

Testimonials

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Drug Discovery Digest

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

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

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Package | Prasara Yoga

Natural Penis Enlargement | The PE Bible

Unblock My Hormones And Start Burning Fat TODAY With HB5

Article FDA Thank You Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Another RICOdiculous Decision

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

Confident Learned Intermediaries Defeat Warning Causation

Guest Post – Curling Up With a Good Reasonable Alternative Design Opinion

Unimpressed Learned Intermediaries Defeat Warning Causation

Another Dismissal in the Birmingham Hip MDL

Taxotere Timing Troubles Persistently Plague Plaintiffs

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