Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. fit in this definition.

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The Pharma Data

MAY 13, 2021

What I learned on the DVDs was the missing link when it comes to evaluation and eventual treatment of my clients planning for patients with muscular dysfunctions.”. This is definitely a program that every fitness trainer should have in their arsenal and not just watch once, but refer to frequently.â??. New York, NY, USA. PlusOne.com.

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The Pharma Data

MAY 13, 2021

There’s also a lot of truth to what he’s saying… Because high insulin levels definitely are one of the major reasons behind your weight loss resistance. 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.

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Drug & Device Law

DECEMBER 21, 2023

The decision simply ignored the minuscule increased risk, and didn’t compare it to the risks of any alternative treatment – or to the risks of leaving the disease, diabetes, untreated. Indeed, this type of disrespect for state authority over state law has been so prevalent in MDLs such as CPAP that we call it the “MDL treatment.”

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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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Drug & Device Law

JANUARY 15, 2024

at 526 (citation omitted). “[R]esearch and innovation in medical equipment and treatment would be inhibited.” 2019), analogously held that the standard for admission of expert testimony was “procedural” and therefore Pennsylvania’s Frye rule applied, not Texas’ stricter expert admissibility standard. Janssen Pharmaceuticals, Inc. ,

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Drug & Device Law

SEPTEMBER 9, 2022

For instance, plaintiffs in the vast majority of cases know that they will need evidence from a prescribing physician, testimony or affidavit for summary judgment and testimony for trial. Two cases are cited in connection with the court’s definition of a novel test for proximate cause for a prescription medical device warnings claim.

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Drug & Device Law

JUNE 23, 2023

We’ve blogged before about the plaintiffs’ self-defeating “injury” definition in the Taxotere mass tort litigation. 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. Plaintiff Adams was typical.

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Drug & Device Law

JUNE 1, 2022

May 25, 2022), the Wisconsin Court of Appeals reversed a lower court’s granting of an injunction compelling treatment with ivermectin. By contrast, the defendant submitted a doctor affidavit that discussed the patient’s history and treatment plan in detail. Aurora Healthcare , 2022 WL 1657559 (Wisc.

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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.” at *3 (internal quotation marks and citations omitted). at *8-10. at *14 (citation omitted).

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