Health Law Advisor

JANUARY 30, 2023

Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester. [1] The lawsuit has sparked concern by both industry and the FDA. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”) [4].

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FDA US Department of Health and Human Services Governance Doctors 59

Bill of Health

JANUARY 30, 2023

As the COVID-19 pandemic and its concomitant social-distancing efforts rendered many, if not most, health visits inaccessible, telehealth platforms and companies swiftly stepped in to allow for virtual patient-doctor consultations. One such platform is Cerebral Inc. ,

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Health Populi

JULY 28, 2020

Since launching in 2008, Withings has developed a portfolio of well-designed, consumer-facing digital health tools such as weight scales, blood pressure monitors, and digital thermometers.

Public Health 116

Public Health COVID-19 Telemedicine FDA 116

Health Law RX

JULY 25, 2022

The EEOC notes that employers will meet the “business necessity” standard when such testing is consistent with current guidance from Centers for Disease Control and Prevention (“CDC”), Food and Drug Administration (“FDA”), and/or state/local public health authorities. GINA Implications of COVID-19 Tests.

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Drug & Device Law

DECEMBER 4, 2023

Taking the good doctor first, In re Philips Recalled CPAP, Bi-Level Pap, & Mechanical Ventilator Products Litigation , 2023 WL 7019667 (Sp. CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. Sinclair v.

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Drug & Device Law

FEBRUARY 21, 2022

11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.” Coloplast Corp. 2022 WL 425206 (N.D.

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FDA Doctors 59

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

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Medicare Medicare FDA Prescription Drug Pricing 52