HIT Consultant

MAY 12, 2022

Notable transactions in the consumer and member tech category include: Pear Therapeutics , software-based medicine provider, made its mark in 2017 as its tool became the first digital therapeutic approved by the FDA with claims to improve clinical outcomes.

COVID-19 98

COVID-19 FDA Licensing 98

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Such power rests solely with the FDA.” The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. 471 (11th Cir. 2d 775, 799 & n.114

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. 124 (2007), which would also be knocked out by Dobbs if it sticks. 472 (2013).

FDA 127

FDA Licensing 127

Drug & Device Law

MARCH 7, 2022

544 (2007), and Ashcroft v. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ? Twombly , 550 U.S. Iqbal , 556 U.S.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Novartis Pharmaceuticals Corp. ,

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. After some FDA inquiries, the defendant eventually submitted a separate 510(k) application for the product, and it was cleared in May of 2008.

FDA 69

FDA Governance Licensing 69