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

Who among us, upon reading FDA's draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses)...

Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd.

The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute ("FDLI")...

The American Conference Institute ("ACI") will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials…

As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent.

Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.

OPDP is coming out! On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots!

Investigators also found that the pharmacy sold pseudoephedrine products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005.

Biosimilars, costing about 50% of their reference products, have generated $56 billion in healthcare savings since 2015, with $20 billion saved in 2024 alone.

Following up on our first post discussing Digital Health Technologies (DHTs) (here), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

The skinny label has hit the big time. Last week, the Supreme Court agreed to hear Hikma v. Amarin to address the burning question of whether a carve-out induces infringement.

On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency.

For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table.

We learned earlier this week that an allision (a runner-up to Merriam-Webster's 2024 Word of the Year, polarization) may be poised to occur—perhaps within a fortnight...

The Wall Street Journal (WSJ) recently published a series of articles as part of its special report "What's Ahead for Artificial Intelligence."

On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines.

Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institute's Annual Conference, continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own.

In our June blog post, we reported on FDA's request for comments about its program to receive information from the public alleging misconduct by other companies.