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Department of Health and Human Services (HHS) › Patents › Food and Drug Administration (FDA)

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

Latham & Watkins LLP on

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Axinn, Veltrop & Harkrider LLP

Biden Administration Promotes Domestic Pharmaceutical Production to Reduce Drug Shortages

Axinn, Veltrop & Harkrider LLP on

I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more

Foley & Lardner LLP

USPTO Underscores Duty of Disclosure Pertaining To FDA Submissions

Foley & Lardner LLP on

The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability … received from or submitted to the...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

MoFo Life Sciences on

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Sheppard Mullin Richter & Hampton LLP

Trade Secret Protection & the COVID-19 Cure: Observations on Federal Policy-Making & Potential Impact on Biomedical Advances

Sheppard Mullin Richter & Hampton LLP on

As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more

Blank Rome LLP

Special Exemptions from Product and Patent Liability for COVID-19 Countermeasures

Blank Rome LLP on

On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published in the Federal Register a “notice of declaration” conferring broad-based immunity from tort (including product liability) litigation for...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Highlights this week include a lame duck update on year-end health bills and tax provisions; lawmakers reacting to a federal judge ruling the Affordable Care Act is unconstitutional; Sen. Hatch seeks to update Hatch-Waxman;...more

Holland & Knight LLP

Healthcare Law Update: June 2017

Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

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