FDA Law

OCTOBER 3, 2022

Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. See 42 U.S.C. 1320a-7b(b). Today, these two documents are key in navigating speaker programs in the industry.

Consulting 105

Consulting Healthcare Professional Specialization Government 105

FDA Law

MAY 5, 2024

The Single Convention requires manufacturing quotas and import/export permits for schedule I substances. Schedule III substances do not require manufacturing quotas. To comply with the treaty obligations as a schedule III substance, DEA may have to require marijuana import/export permits and manufacturing quotas.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

FDA Law

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law

AUGUST 21, 2023

It’s important to note here that the warnings and precautions listed in the acetaminophen labeling complied with FDA’s Pregnancy Rule (which applies to all OTC systemic products), stating “if pregnant or breast-feeding ask a health professional before use,” and with the acetaminophen OTC Monograph and the relevant NDAs.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

MAY 21, 2024

at 44,620-21 The Attorney General, based on OLC advice, concluded that marijuana could be rescheduled to schedule III, and that DEA would consider supplementing schedule III requirements with additional marijuana-specific controls such as manufacturing quotas and import and export authorizations to satisfy treaty obligations.

Physicals 69

Physicals Medical Clinic Emergency Room 69

FDA Law

JUNE 1, 2025

The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians. This year is shaping up a bit differently with all four OPDP enforcement letters addressing healthcare professional materials (including a speaker slide deck!!).

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59