FDA Approval, Testimonials and Trials

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

Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

FDA

FDA Science Regulations Production

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

Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

FDA

FDA Science Regulations Production

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

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

FDA

FDA Science Regulations Production

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

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. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir.

Testimonials

Testimonials FDA Drugs Vaccine

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

FDA Approval

FDA Approval FDA Drugs Production

SJS/TEN Case Survives Motion to Dismiss

Drug & Device Law

OCTOBER 4, 2023

We acquired our trial chops in the Central District of California, where we were an AUSA. Not citing any case where such a distinction had been recognized, the Burton court held the difference between SJS and TEN, and the significance of such difference, to be questions of fact “that will require medical expert testimony to resolve.”

FDA

FDA Testimonials FDA Approval Trials

Another RICOdiculous Decision

Drug & Device Law

JULY 24, 2023

Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.” 2023 WL 4191651, at *8. But that conclusion is premature.

Testimonials

Testimonials Pharmacy FDA Doctors

Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 2023 WL 2386776, *3. citing Gross v. Pfizer, Inc. ,

FDA Approval

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The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA

FDA FDA Approval Testimonials Vaccine

Mixson Somewhat Mixed, But We’ll Take It

Drug & Device Law

NOVEMBER 1, 2022

This is the causation variant that we described here as “ not quite physician failure to read ,” since the pertinent testimony was in the nature of a failure to remember reading the relevant information rather than an absolute “never read it” from the implanter. It is undisputed here that the filter received FDA approval.

Testimonials

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Not the Best Wisconsin Law Decision We’ve Ever Seen

Drug & Device Law

APRIL 18, 2022

The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” Even then Rennick ’s rationale didn’t do a very good job.

Testimonials

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Summary Judgment for Defendants in Hip Implant Case out of the District of Oregon

Drug & Device Law

MARCH 4, 2022

702 – that they were not qualified, their testimony was not based on sufficient facts or data, their methodologies were not reliable, and they did not reliably apply their methodologies to the facts of the case. their testimony does not present a genuine issue of medical fact.” Motion to Exclude Experts. emphasis in original).

Testimonials

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Drug Discovery Digest

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

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

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

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

SJS/TEN Case Survives Motion to Dismiss

Another RICOdiculous Decision

Pro Se Plaintiff Tries and Fails To Plead Claims For Failure To Withdraw And Failure To Warn

The FDA and Feasible Alternative Designs

Mixson Somewhat Mixed, But We’ll Take It

Not the Best Wisconsin Law Decision We’ve Ever Seen

Summary Judgment for Defendants in Hip Implant Case out of the District of Oregon

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