SQA

MAY 17, 2022

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2013 WL 2457950, at *8 (N.D. 2013 WL 1758647, at *5 (D.N.J. Roche Laboratories, Inc.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. The G/N MDL was created in 2013 and mostly settled in 2016.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105