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

FDA is moving with notable speed. Less than a month after announcing its inaugural class of Commissioner's National Priority Voucher (CNPV) winners (see our previous post), the agency has already named its second cohort.

Following up on Donald Trump's May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health...

We recently saw an interesting Instagram post aimed at Swifties disappointed in the election results. It noted that Tay Tay released four albums during the first Trump administration...

With a nod to the immortal phrase, "Bring out your dead! Bring out your dead!" uttered by body collector Eric Idle from the 1975 comedy romp, Monty Python and the Holy Grail...

One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees.

Two Hyman, Phelps & McNamara, P.C. (HPM) Directors, Karla Palmer and Dara Levy, will present at the Puerto Rico Pharmaceutical Summit...

FDA has announced a public meeting and request for comment on proposed recommendations for the next reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032.

Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29.

That's a play on an old acronym, in service of a point.

Administrative Law Judge ("ALJ") John Mulrooney conducted a prehearing conference hearing on Monday, December 2nd, to kick off the public hearing...

FDA's recent support and presentations at meetings on Regulatory Submissions with Real-World Evidence: Successes, Challenges...

On Feb. 2, 2024, FDA's Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM).

We recently published the first part of our review of FDA's draft guidance titled "Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products."

Last month, we blogged on the Department of Justice's (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were "unconstitutional" and that DOJ would no longer defend those removal restrictions in court.

Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails.

Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data...

As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts...