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

On December 18, 2025, the U.S. Food and Drug Administration (FDA or the Agency) published clarification on its enforcement approach under the Modernization of Cosmetics Regulation Act of 2022...

It has been a few weeks, but we thought it important to do a deeper dive on the two Office of Prescription Drug Promotion (OPDP) Untitled Letters published in November.

As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim "healthy." The proposed revised rule constituted a radical change from the original definition of healthy...

A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA's Center for Veterinary Medicine...

Over the past few days, we've been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere...

As we previously discussed, FDA recently held two meetings that, while separate, provided a cohesive discussion of the use of Real World Evidence...

Primacy and recency are recognized psychological phenomena: people tend to remember the first thing they hear, and the last. It's why litigators concentrate on their opening statement to a jury...

FDA's Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib).

On Thursday, November 14, President-Elect Trump announced his pick of Robert Kennedy, Jr., for Secretary of Health and Human Services (HHS).

On Friday, February 23, 2024, FDA announced its final decision to withdraw the approval of Pepaxto (melphalan flufenamide), which was approved...

A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection.

In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology ("AMT") designation from FDA.

On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or "GeMDAC."

The U.S. Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program.

In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order...

On January 23-24, 2024, the American Conference Institute ("ACI") will host its "Advanced Legal, Regulatory and Compliance Forum on OTC Drugs" conference at the Sofitel New York, NY.

The most recent version of the BIOSECURE Act (the "Act") was introduced in the U.S. House of Representatives (H.B. 7085) and Senate (S.B. 3558) on January 25, 2024.

We follow the civil settlements agreed to by the Drug Enforcement Administration ("DEA") and registrants that are announced in press releases by U.S. Attorney's Offices and DEA.