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Mintz
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820...
Duane Morris LLP
The Federal Trade Commission (FTC) has announced its support of the federal government's use of "march-in rights" as a mechanism to control the price of pharmaceuticals.
AlixPartners
Contract development and manufacturing organizations (CDMOs) play a critical role in the pharmaceutical and biotech industries.
Polsinelli LLP
On February 6, 2024, the Federal Trade Commission ("FTC") commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act...
Ropes & Gray LLP
On December 21, 2023, the U.S. Food and Drug Administration ("FDA") published a final rule to allow institutional review boards ("IRBs") to waive or alter informed consent for certain clinical...
Holland & Knight
The U.S. Patent and Trademark Office (USPTO) issued new guidance on Feb. 12, 2024, regarding the use of artificial intelligence (AI) while developing new inventions.
Polsinelli LLP
On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR)...
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings...
Greenberg Traurig, LLP
In its latest global regulatory harmonization effort, on Feb. 2, 2024, the FDA published a final rule amending the cGMP requirements for medical devices contained in the QSR...
Steptoe LLP
In Part 13 of our StepLadder Series, we discussed the US Food and Drug Administration's (FDA) regulation of adhesives used in food-contact applications.
Axinn Veltrop & Harkrider
Can a drug manufacturer refuse to provide samples of its innovator product under the CREATES Act if it thinks that the requester will not actually use them to develop a biosimilar...
Crowell & Moring LLP
In Vanda Pharmaceuticals, Inc. v. United States, No. 23-629C (Fed. Cl. 2024), 2024 WL 201890, the Court of Federal Claims (COFC) addressed whether government disclosure of a company's trade secrets...
Proskauer Rose LLP
The Departments of Labor, Treasury, and Health and Human Services recently issued guidance for group health plans outlining a "therapeutic equivalence" medical management technique for required preventive services coverage of contraceptives.
Goodwin Procter LLP
Today, the district court for the Western District of Texas granted the government's motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price...
Proskauer Rose LLP
This year's Health and Mental Hygiene Bill ("HMH Bill") (part of the Governor's FY 2025 Executive Budget, which proposes a $233 billion balanced budget)...
Perkins Coie LLP
The U.S. Food and Drug Administration (FDA) recently released an updated list of guidance documents that the agency plans to publish in draft or final form throughout 2024.
Frantz Ward
Frantz Ward's Labor & Employment Group has previously written about the Ohio Bureau of Workers' Compensation's treatment of marijuana in its Drug-Free Safety Program (DFSP) following the legalization...
Manatt, Phelps & Phillips LLP
On December 15, 2023, the CMS Innovation Center (CMMI) announced a new voluntary model for state Medicaid agencies called Transforming Maternal Health (TMaH).
Hyman, Phelps, & McNamara
With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985...
Ropes & Gray LLP
On February 2, 2024, the U.S. Food and Drug Administration ("FDA") published a final rule1 to amend the current good manufacturing practice requirements...
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