2008, Compliance and FDA - Health Care Compliance Brief

Unpacking Averages: Likelihood of FDA Medical Device Inspections

Health Law Advisor

JANUARY 4, 2022

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state. Indeed, FDA includes such a map in its newly released dashboard for FDA inspections. Some years FDA may conduct many inspections; other years not so many.

FDA

FDA Compliance

Harnessing Health Technology and Precision Data to Transition to Proactive Healthcare

HIT Consultant

NOVEMBER 3, 2024

Moreover, wearable technology faces a multitude of challenges, including ensuring accuracy, security, interoperability, and regulatory compliance. While many consumer-grade wearables may not fall under FDA regulations, the data they collect necessitates adherence to stringent data privacy laws.

Regulatory Compliance

Regulatory Compliance Telemedicine FDA Health Outcomes

Monitor Improper Payments for Part C and Part D with Medicare Audit and Monitoring Software

Innovaare Compliance

MARCH 1, 2022

Examples of improper payments include: Unusual quantities or administration frequency of Part B drugs; Drugs for non-FDA approved indications (e.g., Since 2008 Inovaare has provided healthcare organizations with cost-effective quality services to help them comply with Medicare regulations and improve their operations, thereby saving costs.

Medicare

Medicare Medicare Overpayments Overpayment

Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

Healthcare Law Blog

OCTOBER 25, 2023

iii] The Act also authorizes the CT DCP to impose penalties for instances of non-compliance or violations of the Act. xii] SafeRx Amendment Act of 2008. xi] Washington D.C. ix] Municipal Code of Chicago Sec. x] Drugs and Medicine – Diabetes – Records and Recordation. 2017 Nevada Laws Ch.

Licensing

Licensing Compliance FDA Public Health

The Wait is Over. Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

Telemedicine

Telemedicine COVID-19 FDA Compliance

Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

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

FDA Compliance

States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. 18 U.S.C. §

Telemedicine

Telemedicine COVID-19 Fraud Licensing

Thinking About the FDA’s Alternative Summary Reporting Program

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

FDA

FDA Fraud Governance Compliance

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v.

FDA

FDA Fraud Compliance

Logical Contradiction Doctrine: Buckman for Textualists

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Lohr , 518 U.S.

FDA

FDA Fraud Governance Medicare

Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs

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. Jackson Women’s Health Org. ,

FDA

FDA Public Health Federal Policy Doctors

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance

Compliance FDA Fraud

Health Care Compliance Brief

Unpacking Averages: Likelihood of FDA Medical Device Inspections

Harnessing Health Technology and Precision Data to Transition to Proactive Healthcare

Trending Sources

Monitor Improper Payments for Part C and Part D with Medicare Audit and Monitoring Software

Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

The Wait is Over. Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

Unpacking Averages: Assessing the Racial Composition of Drug Clinical Trial Subjects

States and Feds Signal Big Changes to Telehealth Prescribing

Thinking About the FDA’s Alternative Summary Reporting Program

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Logical Contradiction Doctrine: Buckman for Textualists

Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

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