PLOS: DNA Science

OCTOBER 19, 2023

Also recently, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committe turned down a stem cell treatment for amyotrophic lateral sclerosis, aka ALS, Lou Gehrig’s disease, or motor neuron disease. The only treatment for ALS is a drug, Riluzole , taken as a tablet or a film. The pace though varies quite a lot.

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Therapies FDA Clinical Trials DNA 104

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. 3d , 2023 WL 4191651 (C.D. PATDC82 II , 2023 WL 4191651, at *3. 2023 WL 4191651, at *8.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

JUNE 15, 2023

Ladapo , 2023 WL 3833848 (N.D. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. 2023 WL 3833848, at *3. There are well-established standards of care for treatment of gender dysphoria.” Doe , 2023 WL 3833848, at *2. 2023 WL 3833848, at *2.

Doctors 122

Doctors Testimonials Treatment International 122

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

OCTOBER 30, 2023

3d , 2023 WL 5807340 (D. G/N , 2023 WL 5807340, at *1. G/N , 2023 WL 5807340, at *9 (plaintiffs’ experts “conducted no independent studies” and “explicitly relied on” the memo as the basis of their opinions). Until a little while ago. Those plaintiffs were in trouble because all of their experts slavishly relied on the memo.

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Testimonials Production Doctors Treatment 59

Drug & Device Law

JUNE 14, 2023

Sometimes expert testimony bolsters the warnings story for one or both sides, but not always. 2023 WL 3589654 (Ariz. May 23, 2023). The doctor prescribed Cipro for the plaintiff after a urological procedure. If a doctor’s treatment of a patient is negligent, that usually spells medical malpractice.

FDA 59

FDA Doctors Testimonials Production 59

Drug & Device Law

OCTOBER 24, 2023

Defining “inconsistency” liberally, plaintiffs try to use sales reps to get around the learned intermediary doctrine often without much more evidence than that the sales rep visited the prescribing doctor. A step in the right direction of keeping the doctors in the foreground of the analysis. Depuy Orthopaedics, Inc. LEXIS 54471 (N.D.

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Testimonials Doctors Production Treatment 59