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

Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here, here, and here).

Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program.

FDA recently released a draft guidance, titled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products,"...

In most instances, it is clear if a product will be considered a "device" under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Sometimes, though, the question of classification defies an easy answer.

Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny.

Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission.

On January 6, 2025, FDA released two final guidance documents on food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food.

On September 15, 2023, FDA released a final guidance document titled "Breakthrough Devices Program." Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program ...

Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy think again!

It's been a couple of months since the dust has settled from FDA's October 26, 2016 approval of Mylan Pharmaceuticals Inc.'s ANDA 078276 for a generic version of Daiichi Sankyo Inc.'s BENICAR Tablets...

We are still parsing through the May 12 Executive Order (EO), "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" ...

The trio of CDER, CBER, and CDRH released a new draft guidance titled "Use of Data Monitoring Committees in Clinical Trials" that revises the 2006 guidance...

Over the last three and a half years, meetings with FDA were conducted virtually.

As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products.

This announcement addresses one of the commitments in FDA's Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

On November 19, 2024, FDA released a draft guidance titled "Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products." As much of the content...

Last week, in a letter thanking President Joe Biden for his leadership to federally reschedule cannabis, Democratic governors sought to make the case for rescheduling...

Last October President Joe Biden asked the Secretary of the Department of Health and Human Services ("HHS") and the Attorney General to "initiate the administrative process to review expeditiously how marijuana is scheduled under federal law."