Exeed Regulatory Compliance

MARCH 5, 2020

Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb. Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Dot Compliance

SEPTEMBER 11, 2022

Prior to ISO 9001:2015, the standard for Quality Management Systems (QMS) was ISO 9001:2005. The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The rules of RDC 786/2023 correspond to a normative update, which replaces RDC 302/2005.

FDA 40

FDA Compliance COVID-19 World Health 40

Bill of Health

AUGUST 29, 2022

They are at the mercy of authority figures from multiple systems—the judiciary, government officials who oversee their day-to-day health, safety, and wellbeing, parents or legal guardians who may retain control over their bodily autonomy and decision making, and service providers who have access into the story of their lives. 624, 63 S.Ct.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Kaiser Health News

FEBRUARY 9, 2023

The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. And in a lot of places, losing access to medication abortion means losing access to all abortion because there aren’t clinical services available.

US Department of Health and Human Services 52

US Department of Health and Human Services Medicare Medicare FDA 52

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. Central Medical Health Services, Inc. , In state court, Creazzo remains binding precedent. 2d 521 (Pa. 3d 1245 (N.J. 2d at 1013-14.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

FDA 52

FDA Governance 52