Dot Compliance

JUNE 16, 2022

Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

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FDA Regulatory Compliance Compliance Governance 52

MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. The 2016 edition of USP <800> provided comprehensive guidance on handling and administering drugs.

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Compliance FDA Regulatory Compliance Hospitals 52

Dot Compliance

JANUARY 14, 2022

There are many risk management regulations and compliance standards in the life sciences industry that must be followed to successfully maintain business operations and ensure the safety of staff and product users. Key risk management regulations for Life Sciences companies include: ISO 12485:2016. Source: [link]. Source: [link].

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Compliance FDA Regulatory Compliance Governance 52

Exeed Regulatory Compliance

APRIL 6, 2020

Recently, the FDA has authorized the emergency use of the Battelle CCDS Critical Care Decontamination System , which uses vapor phase hydrogen peroxide to decontaminate N95 or N95-equivalent respirators for reuse by healthcare personnel. This is one of the criteria used by the FDA for granting the Emergency Use Authorization.

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COVID-19 FDA Public Health 52

SQA

OCTOBER 18, 2022

Policymakers, regulators, and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus. United States Food and Drug Administration (FDA) – Regulations and Guidances. PDA Technical Report No.

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US Department of Health and Human Services FDA COVID-19 Compliance 40

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JUNE 5, 2023

April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible. The Kelley court agreed with the defendant.

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FDA Regulatory Compliance Compliance Fraud 59