FDA Law
MARCH 6, 2024
FDA Law Blog readers can use discount code S10-866-866L24.S Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. More information about the conference can be found here. S for reduced registration fees.
FDA Law
JANUARY 15, 2024
FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.
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FDA Law
OCTOBER 6, 2021
By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. Code Ann.§
FDA Law
NOVEMBER 14, 2022
Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.
FDA Law
JUNE 15, 2022
The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Improvement, and Modernization Act in 2003.
FDA Law
MAY 2, 2022
They are the most stringently regulated substances of abuse and it is unlawful to manufacture and distribute them. 21 U.S.C. § It is important to understand the lead up to Garland’s stance. Jefferson B. Sessions, Memorandum for All United States Attorneys, Jan.
FDA Law
OCTOBER 24, 2024
Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however. Cook-Deegan et al.
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