The Pharma Data

MAY 13, 2021

I could hear doctors and nurses speaking in hushed tones…. And Mary-Anne, a nurse from Arkansas, who says…. Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. There were countless sensors and monitors hissing and beeping around me.

Production 52

Production Packaging Doctors Research 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

NOVEMBER 9, 2023

552 (2011); Thompson v. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

FDA 64

FDA Nurses Production Regulations 64