Michael Werner

Holland & Knight LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA Issues Guidance on Expanded Access Use of Investigational Drugs

The U.S. Food and Drug Administration (FDA) issued three final guidance documents on June 2, 2016, that address FDA's rules and regulations governing "expanded access" to investigational drugs. The expanded access process –...more

6/9/2016 / Drug Approvals , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , IRB , Pharmaceutical Industry , Prescription Drugs

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

7/25/2014 / Congressional Investigations & Hearings , Corporate Counsel , DEA , Enforcement , Food and Drug Administration (FDA) , Illegal Drugs , Manufacturers , Marijuana , Pharmaceutical Industry , Scientific Research

Drug Quality and Security Act Gives FDA Authority to Regulate Drug Compounding and Creates Uniform Federal Standards for...

On Nov.18, Congress enacted sweeping changes to the laws governing the safety of the drug supply. The Drug Quality and Security Act (the act) clarifies FDA's authority to regulate drug compounding. It also creates uniform...more

11/19/2013 / Drug Distribution , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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