News & Analysis as of

Clinical Trials Drug Testing Pharmaceutical Industry

Wilson Sonsini Goodrich & Rosati

Clinical Studies of Dietary Supplements Could Trigger IND Requirements

In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more

Patrick Malone & Associates P.C. | DC Injury...

With speeding vaccine clinical trials, a pause that may prove reassuring

The “warp speed” race to develop a Covid-19 vaccine has gotten hit with a yellow flag....more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

Holland & Knight LLP on

On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

Smart & Biggar

Rx IP Update - May 2018

Smart & Biggar on

An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

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