Advarra

MARCH 6, 2025

Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Advarra ensures that clinical trials comply with the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Bioethics 52

FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

Hospitals 59

Hospitals Nurses Compliance Pharmacy 59

Advarra

APRIL 30, 2024

In some countries, local regulations may indicate the sub-investigators need to sign as well. Both the medical licenses and nurse licenses need to be up to date. Pharmacy File Ensure inventory records are up to date. Determine if there is a separate delegation log in pharmacy or included in ISF.

Licensing 52

Licensing Licensing Pharmacy FDA 52

Advarra

SEPTEMBER 7, 2023

Together, these three principles form the foundation upon which HRPPs were established and provide the basis for laws, regulations, guidelines, and policies governing human subjects research. They must ensure research is conducted in compliance with the protocol and applicable policies and regulations.

Research 52

Research Clinical Trials Compliance Regulations 52

Perficient: Drug Development

MARCH 19, 2024

And the cycle deepens and worsens with every newly departing nurse or physician — many of whom can’t or won’t be replaced due to budget freezes or an inadequate supply of potential candidates. It also presents significant risks to patient safety, the quality of care at affected organizations, and the sustainability of those HCOs.

Pharmacy 52

Pharmacy Nurses Marketing Engineering 52

FDA Law Blog: Biosimilars

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. 2] Why is this an issue? the “ultimate user”). the “ultimate user”).

Nurses 98

Nurses Therapies Regulations Pharmacy 98

Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

Testimonials 105

Testimonials Drugs FDA Vaccine 105