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

I became a Diversion Investigator with the Drug Enforcement Administration ("DEA") in 1986, but it only recently dawned on me that my relationship with the agency actually began as a ninth grader about 14 years earlier.

The government is currently funded through March 14th, 2025. Come Monday March 17th, if Congress does not pass a budget or continuing resolution...

Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life...

Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight...

In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).

This finalized a draft guidance issued in December 2021, largely similar in substance.

As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, in late December.

We previously blogged about the Commissioner's National Priority Voucher (CNPV), FDA's new pilot program to expedite the reviews of selected...

On September 15, 2020, I posted an article in this blog entitled "Trump Embraces International Reference Pricing in Executive Order," which described an order in Trump's first administration to use most-favored-nation...

FDA recently issued a draft guidance, Chemical Analysis for Biocompatibility Assessment of Medical Devices, which describes chemical characterization methods that may be used to demonstrate...

As part of the review of a BLA, NDA, or ANDA, FDA assesses the manufacturing facilities named in the application to determine whether they can perform the proposed manufacturing operations...

"Human sacrifice! Dogs and cats living together! Mass hysteria!" At least that's this blogger's reaction to the recent news that FTC sent out Notice letters to 10 different drug companies...

FDA has authorized more than 1,200 artificial intelligence (AI)-based digital devices for marketing.

The rare pediatric disease priority review voucher program remains in its sunsetting state – the current authority only allows for granting of such vouchers...

On Friday, August 25, 2023, FDA released a much-anticipated Final Guidance titled, "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act," ...

President Donald Trump's Executive Order directed the Attorney General last month to expedite the completion of marijuana rescheduling...

FDA, like much of the rest of the world, has been adjusting to the rapid changes in our world these last few years. For nearly three years following the declaration...