The Pharma Data

MAY 14, 2021

All the scientific studies… And the words straight from a doctor’s mouth… So you’ll have everything you need… By the way, my name is Matt Stirling. But what scientists and doctors are finally starting to realize… Is if you want to get the fat out of your cells…. Leading to a bigger stomach….

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Agency IQ

MAY 28, 2024

FDA’s Laboratory Developed Test (LDT) Rule Quick background: The FDA recently published a new final rule to formally extend regulatory oversight over laboratory developed tests (LDTs), which the agency has long maintained are a subset of in vitro diagnostics (IVDs) and therefore should be regulated as a medical device in the U.S. Thank you.

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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

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Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” E.g. , Estee Lauder, Inc. FDA , 727 F. 1, 6 (D.D.C.

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Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” That’s why Buckman Co. 341 (2001), is so important.

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Drug & Device Law

DECEMBER 5, 2022

at 451-52; The evidence failed to establish the contents of the defendants’ oral marketing communications, and thereby failed to show those communications met the “likely” to deceive standard, id. The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.”

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Drug & Device Law

JULY 18, 2022

2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required by 21 U.S.C. The two biggies, of course, are the definitions of “drug” and “device” found in 21 U.S.C. Emphasis added).

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Drug & Device Law

AUGUST 8, 2022

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. 23 in its current form. at *3) Rule 23(c)(4) partial class. 3d 211 (D.N.J.

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Drug & Device Law

MARCH 22, 2022

But a vaccine’s label can be changed unilaterally by the manufacturer under the “changes being effected” (CBE) regulation to reflect “newly acquired information” concerning warnings and adverse reactions, among other things. In Albrecht , part one had been conceded.

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Drug & Device Law

FEBRUARY 14, 2024

In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss. The court also ordered a more definite statement with respect to the manufacturing defect claim. Alcon Laboratories, Inc. 2024 Ohio Misc. Pleas Feb.

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