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.

Manufacturing 115

Manufacturing IT Provider ER 115

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.

Manufacturing 64

Manufacturing Clinic IT Vaccination 64

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. If FDA’s evidentiary expectations are set too high, it could undermine the intent of the new guidance.

Medical 53

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FDA Law

MAY 21, 2024

DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614. Basis at 61; NPRM at 44,615. Basis at 24; NPRM at 44,617.

Physicals 69

Physicals Medical Clinic Emergency Room 69