Your search for ‘Hyman, Phelps, & McNamara’ returned 249 results

In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities...

Last month the U.S. Attorney's Office for the Northern District of Illinois announced that Walgreens agreed to pay up to $350,000,000 to resolve...

As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device...

As part of FDA's Prescription Drug User Fee Act (PDUFA) VII goals published in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027...

On December 5, FDA's Digital Health Center of Excellence announced the "Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot," in conjunction with the Center for Medicare and Medicaid Innovation Advancing Chronic Care with Effective, Scalable Solutions model.

In October 2021, FDA and MHRA (United Kingdom's Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles...

The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C. Counsel John Claud to testify yesterday...

In light of the fast-approaching compliance date of February 2, 2026, FDA convened a town hall discussing last-minute issues governing its priorities for the Quality Management System Regulation...

On January 18, 2024, the director of FDA's Center for Devices and Radiological Health and the chief medical officer and acting director of CMS' Center for Clinical Standards and Quality...

FDA recently issued a draft guidance, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (link), which describes information...

In 2009—15 years ago— the National Organization for Rare Disorders (NORD) announced the first U.S. recognition of Rare Disease Day.

The Drug Enforcement Administration ("DEA") has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit...

During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco.

For years, submitting a Suitability Petition has been like screaming into a void: You'd be lucky if FDA ever responds.

At issue are seventeen advertisements which, according to POM, the FTC incorrectly determined are misleading.

President Donald Trump signed an Executive Order on Thursday last week directing the Attorney General to expedite completion of marijuana rescheduling begun...

In August 2023, the U.S. Department of Health and Human Services ("HHS"), based on the federal Controlled Substances Act's ("CSA's") Eight Factor Analysis...

On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS), through its Center for Medicare and Medicaid Innovation, announced the upcoming...