Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.

FDA 52

FDA Compliance 52

SQA

SEPTEMBER 2, 2022

ISPE Good Practice Guide: Critical Utilities GMP Compliance. United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems .

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

Informed Consent 40

Informed Consent FDA Compliance Regulatory Compliance 40

HIPAA Journal

OCTOBER 21, 2022

Keith Ritson, 42, of Bayville, New Jersey, is a former pharmaceutical sales representative who promoted compound prescription medications and other drugs between 2014 and 2016.

Fraud 63

Fraud HIPAA FDA Health Insurance 63

Hall Render

JULY 17, 2024

Could FDA Action Be Next? senators sent a letter to the Food and Drug Administration (“FDA”) urging the agency, which has jurisdiction over the advertising of prescription drugs, to update its guidelines on social media advertising. The FDA has not updated its guidance since 2014. In February 2024, two U.S.

FDA 40

FDA Compliance 40

Hall Render

JANUARY 3, 2024

Liza Brooks is based in the firm’s Detroit office and focuses her practice on supply chain operations, health information technology and clinical research compliance. from the University of Dayton School of Law in 2014. office and helps clients navigate the complex and ever-changing landscape of FDA regulation.

Fraud 40

Fraud Hospitals Compliance FDA 40

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. 26 of 2014. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 52

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 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 measure may allow the expansion of the population’s access to diagnostic procedures in the country.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). As such, manufacturers and importers that have already submitted their applications to CDSCO may continue marketing their devices in India as they prepare for compliance.

COVID-19 52

COVID-19 FDA COVID-19 Vaccine Compliance 52

SQA

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

FDA 52

FDA COVID-19 Compliance Governance 52

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides.

FDA 52

FDA Compliance COVID-19 Public Health 52

Bill of Health

MAY 28, 2024

The process of rescheduling may be long and is unlikely to create a pathway to federal compliance for state-legal marijuana businesses without further federal legislation. Since 2014, Congress has passed spending amendments that limit the use of federal funds for enforcement against state-compliant medical marijuana programs.

FDA 214

FDA Bioethics Compliance Telemedicine 214

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. In 2021, a CT scan revealed the clips had migrated.

FDA 52

FDA Fraud Doctors Governance 52

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 410 repeal in Law360 (i.e.,

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

MARCH 13, 2023

That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 ( Henderson ) and 2014 ( Lance ), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) ( Creazzo ), all rejecting application of strict liability principles to prescription medical products. E.g. , Lewis v. 3d 357 (3d Cir.

FDA 59

FDA Compliance Governance Doctors 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.”. 3d 467, 477 (E.D.

FDA 59

FDA Licensing Compliance 59

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. Patrick , 2014 WL 1454696 (D.

FDA 116

FDA Public Health Federal Policy Doctors 116

Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. Today’s post focuses not on the exception to the compliance presumption but on the antecedent issue of when the presumption applies.

Compliance 59

Compliance FDA Fraud 59

Drug & Device Law

MARCH 29, 2022

2228 (2014), and since we do not want to suggest that POM Wonderful had any effect on preemption, we restate the distinction here. While case specific holdings on the issue vary, the general principle is that if a Lanham Act claim challenges an FDA policy choice, meaning the court has to interpret or enforce FDA regulations, it is barred.

FDA 59

FDA Governance Compliance 59