DEA The United States Food and Drug Administration

News & Analysis as of

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

The Proponent Testimony Goes Unrefuted As Renowned Physician Dr. Sue Sisley Highlights The Testimony Of Ten Witnesses Before The...

Thursday, February 17, 2016, was the first evening session of the Ohio House of Representatives’ Medical Marijuana Task Force (“Task Force”), which heard a full complement of testimony, all in support of legalizing medical...more

FDA Regulatory and Compliance Monthly Recap — November 2015

Bill that refines marketing exclusivity for DEA scheduled drugs becomes law - The Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639) was passed in the House of Representatives and was sent to...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

Bringing Predictability and Speed to DEA’s Scheduling of New Drugs

A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New...more

Washington Healthcare Update

This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

Legal Landscape and Guidance for Companies Involved in Marijuana Activity

Many states now permit the use of marijuana for medical or recreational purposes and the federal government has revised certain enforcement policies related to marijuana-related crimes. The possession, use,...more

DEA Issues Proposed Rule Up-Scheduling Hydrocodone Combination Products from Schedule III to Schedule II

On February 27, 2014, the Drug Enforcement Administration (DEA) proposed an up scheduling for hydrocodone combination products under the Controlled Substances Act (CSA) from Schedule III to Schedule II. If the proposed...more

Disposing Of Pharmaceutical Waste: Some Progress

In 2008, the U.S. Environmental Protection Agency (EPA) seemed to be on the road to providing some much-needed clarity to hospitals and other medical facilities concerning the disposal of pharmaceuticals by proposing that...more

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