Remove Doctors Remove FDA Remove Informed Consent Remove Licensing
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. United States Food and Drug Administration (FDA) – Regulations and Guidances. Additional details for each annex are provided within the content section of the document.

FDA 75
article thumbnail

Health Provider News – February 10, 2023

Hall Render

deal to buy national physician practice Support grows for association health plans as small employer insurance costs soar Connecticut doctors call on legislature to tackle prior authorization during this year’s session CT hospitals support student-loan forgiveness, debt-free college programs to boost healthcare workforce DC D.C.’s

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

Drug & Device Law

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. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105
article thumbnail

Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

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.

Doctors 52
article thumbnail

S.D. Texas Trims Back Mesh Plaintiff Regulatory Expert Opinions

Drug & Device Law

Speaking of clothing, sometimes plaintiff regulatory experts engage in cosplay, donning a quasi-military uniform from their service in the FDA many decades ago. This masquerade occurs despite the fact that the expert’s prior FDA position had little or nothing to do with the subject of the litigation. Note that we said “almost.”