Bill of Health

APRIL 7, 2023

Research centers and companies that received government funds are typically allowed to manage their contractual and licensing terms independently with their commercial partners. Shamnad Basheer, a stalwart Indian IP lawyer, proposed in 2012 an ‘investment protection regime’ for innovation that fits well in the mRNA context.

COVID-19 Vaccine 144

COVID-19 Vaccine COVID-19 Governance Public Health 144

Hall Render

AUGUST 10, 2023

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

Bill of Health

JUNE 1, 2023

Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban. By Doron Dorfman On May 11, the U.S. Despite this nuance, the new policy categorically excludes PrEP users.

FDA 228

FDA Public Health Licensing 228

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. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA 127

FDA Licensing 127

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. 2012 WL 3265002, at *5 (N.D. Such power rests solely with the FDA.” The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

MARCH 7, 2022

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 ? 2012); Sieloff v. 2012 WL 5835396, at *1 (D. Medtronic, Inc. ,

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2012) (citing Smith–Haynie v.

FDA 59

FDA Licensing Compliance 59