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Article
AstraZeneca's Challenge To Price Negotiation Fails In Federal District Court
Last Friday, the Delaware District Court rejected AstraZeneca's lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS's guidance implementing it.
United StatesFood, Drugs, Healthcare, Life Sciences
Hyman, Phelps, & McNamara
Article
FDA Knows Its Own Strength—And It Includes Concentration
While the Biologics Price Competition and Innovation Act ("BPCIA") is inherently distinct from the Hatch-Waxman Act.
United StatesFood, Drugs, Healthcare, Life Sciences
Hyman, Phelps, & McNamara

Surely You Must Be Kidding, PTO?!? "No, And Don't Call Me Shirley!" – The Seemingly Slapstick (But Yet Unfunny) World Of Recent Patent Term Extension Decisions (PART 3 . . . And PART 3½)

After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. Patent and Trademark Office ("PTO") Patent Term Extension ("PTE")...

United StatesIntellectual Property

Hyman, Phelps, & McNamara

Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List)

This time last year, we wrote about a long-overlooked FDA statutory authority and wondered if this provision, known colloquially as the "single study plus confirmatory evidence" pathway...

United StatesFood, Drugs, Healthcare, Life Sciences

Hyman, Phelps, & McNamara

A Final LDT Rule In April!? Will FDA Be Prepared?

With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule...

United StatesFood, Drugs, Healthcare, Life Sciences

Hyman, Phelps, & McNamara

Can The Tropical PRV Have Its Moment (Again?) – Not All Priority Review Vouchers Are Created Alike: What The Potential Loss Of The Rare Pediatric PRV Could Mean For The Tropical Disease PRV Program

Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws.

United StatesFood, Drugs, Healthcare, Life Sciences

Hyman, Phelps, & McNamara

Agricultural Bioengineering: The Shifting Landscape

The field of bioengineering is rapidly evolving with new tools that allow for simple, efficient, and highly-specific DNA and RNA editing.

United StatesFood, Drugs, Healthcare, Life Sciences

Foley & Lardner LLP

Weekly Washington Healthcare Update - May 27, 2014

This Week: Multiple House committees examine Medicare payment policies and reforms... Finance Committee advances Burwell HHS Secretary nomination.

United StatesFood, Drugs, Healthcare, Life Sciences

McGuireWoods LLP

Can What The Supreme Court Said About Device Clearance In Lohr, A "Derelict On The Waters Of The Law," Finally Be Sunk?<sup>1</sop>

Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device's...

United StatesFood, Drugs, Healthcare, Life Sciences

Butler Snow LLP

Showing 241–249 of 249 results

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