Sharps Compliance

MAY 11, 2022

Between 2010 and 2018, there were 48,000 accidental prescription opioid exposures among young children.3. Continue reading FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics at Sharps Compliance Blog.

FDA 82

FDA Compliance 82

Innovaare Compliance

JANUARY 15, 2024

2] The current Coverage Gap Discount Program (CGDP), pursuant to the Affordable Care Act 2010 , [3] will be sunset on December 31, 2024. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D.

Medicare 52

Medicare Medicare Compliance FDA 52

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1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. million Americans.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals FDA Telemedicine 96

C&M Health Law

JANUARY 25, 2023

Section 1001 of the Act delays the 4% Statutory Pay-As-You-Go Act of 2010 (PAYGO) sequester for two years, through the end of calendar year 2024. In addition, Section 1331 of the Act authorizes grants to states to enforce and ensure compliance with mental health and substance use disorder parity requirements.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

AUGUST 8, 2022

So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. Smith, LLC , 2010 WL 11566367, at *7 (N.D. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . 471 (11th Cir.

Doctors 52

Doctors Fraud Licensing Compliance 52

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.”. 2010 WL 894054 (N.D.

FDA 59

FDA Licensing Compliance 59