News & Analysis as of

Department of Health and Human Services (HHS) Registration Requirement

Goodwin

DEA Proposes Three-Tiered Special Registration System for Prescribing and Dispensing of Controlled Substances

Goodwin on

On January 15, 2025, the Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) issued a series of rules relating to the telemedicine prescribing of controlled substances, including a proposed...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

BakerHostetler on

Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

Schwabe, Williamson & Wyatt PC

The Importance of Active Registration: Lessons for Federal Contractors

On May 23, 2023, the Court of Federal Claims (COFC) granted a preliminary injunction halting the award and performance of a contract awarded to Cloud Harbor Economics, LLC Cloud Harbor from the Department of Health and Human...more

Bricker Graydon LLP

HHS releases new buprenorphine practice guidelines, relaxing waiver requirements

Bricker Graydon LLP on

The Department of Health and Human Services (HHS) recently released new practice guidance on buprenorphine administration in an effort to make evidence-based treatment for opioid use disorder more accessible to persons...more

Hogan Lovells

CMS proposes requiring drug prices in TV ads

Hogan Lovells on

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Tucker Arensberg, P.C.

Pennsylvania Department of Health Finalizes Regulations for Physicians and Practitioners

The Pennsylvania Department of Health, just released the final Physicians and Practitioners Temporary Regulations. Back in April, I wrote about the regulations that were available for physician comments....more

Hogan Lovells

Compliance Deadline for New ClinicalTrials.gov Regulations is Tuesday April 18 2017

Hogan Lovells on

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results submission on the ClinicalTrials.gov...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

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